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    Denali-Sanofi scraps mid-stage study for multiple sclerosis drug

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    New Beyfortus Data Featured At IDWeek On RSV In Infants

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    Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Sanofi Genzyme is the specialty care global business unit of Sanofi, a leading pharmaceutical company. Sanofi Genzyme is dedicated to developing and delivering innovative treatments for patients with rare diseases, blood disorders, neurology, immunology and oncology, aiming to set new industry standards through groundbreaking innovation and scientific breakthroughs. The company combines scientific expertise, advanced technologies, and patient-centric approaches to drive research, development and manufacturing of breakthrough therapies. Sanofi Genzyme continues to be at the forefront of biotechnology and precision medicine.

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    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally.  Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go.  It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.
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    #PharmaFlow by PHARMACOMPASS
    19 Sep 2024
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    Novartis, GSK, Sanofi, BMS shell out over US$ 10 bn in dealmaking, as mid-size deals take centerstage in 2024

    Novartis, GSK, Sanofi, BMS shell out over US$ 10 bn in dealmaking, as mid-size deals take centerstage in 2024

    The world of pharmaceuticals and biotechnology continued to evolve this year with strategic alliances reshaping industry contours. With mid-size deals taking centerstage, the growth trajectory appears to be marked by a balance of both caution and calculated ambition.The deal-making environment was robust in 2023, with over 2,000 unique pharma and biotech deals totaling more than US$ 410 billion, according to the PharmaCompass database. Last year, there were over 200 mergers and acquisitions (M&As) with transactions exceeding US$ 160 billion in total value. Oncology, infections and infectious diseases, and neurology had emerged as the top three therapeutic areas for deals.PharmaCompass’ analysis indicates that the momentum has been maintained in 2024. As of August 6, the industry had seen over 1,200 unique deals valued at more than US$ 230 billion, including over 120 M&A transactions surpassing US$ 60 billion in aggregate value. While oncology maintains its lead position, neurology and immunology have gained notable traction.The one big difference is that 2024 is yet to witness a mega-deal, comparable to Pfizer’s US$ 43 billion acquisition of Seagen in 2023 or Amgen’s US$ 27.8 billion Horizon buyout announced in 2022. The largest transaction thus far has been Novo Nordisk Foundation’s US$ 16.5 billion acquisition of Catalent, a contract development and manufacturing organization (CDMO).This compilation does not include deals related to acquisition of facilities, divestment, medical devices, diagnostics and animal health. We have considered deals announced, irrespective of when these transactions were completed. For a comprehensive overview of CDMO deals and developments in 2024, please refer to our dedicated roundup.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Vertex buys Alpine Immune for US$ 4.9 bn; Gilead’s CymaBay buyout pays off via FDA nodAmongst the biggest acquisitions of 2024 was Vertex Pharmaceuticals’ buyout of Alpine Immune Sciences for US$ 4.9 billion. It granted Vertex access to protein-based immunotherapies, including the promising povetacicept for IgA nephropathy, a serious kidney disease.Gilead Sciences’ acquisition of CymaBay Therapeutics for US$ 4.3 billion in February secured it access to seladelpar (Livdelzi), an experimental drug that received FDA’s accelerated approval this month for primary biliary cholangitis, a liver disease that affects the bile ducts. Eli Lilly bolstered its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market by purchasing Morphic Holding for approximately US$ 3.2 billion in July. Through this deal, Lilly gained the oral IBD therapy candidate MORF-057, which will offer a more convenient dosing option compared to injectable drugs currently available in the market. Lilly sees the IBD space as a way to diversify beyond obesity.Merck expanded its ophthalmology portfolio by acquiring Eyebiotech Limited for US$ 1.3 billion (plus US$ 1.7 billion in milestone payments), obtaining Restoret for diabetic macular edema and neovascular age-related macular degeneration.Japanese drugmaker Ono Pharmaceutical acquired Deciphera Pharmaceuticals for US$ 2.4 billion, gaining Qinlock for gastrointestinal stromal tumors and vimseltinib for tenosynovial giant cell tumors. Sanofi targeted rare diseases by purchasing Inhibrx for up to US$ 2.2 billion. The acquisition gave the French drugmaker access to INBRX-101 for Alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver damage.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available)  Novartis buys two oncology firms for their assets; J&J, Genmab join ADC bandwagonNovartis has been on a shopping spree, and has made two significant purchases this year. First, it acquired MorphoSys for € 2.7 billion (US$ 2.9 billion), thereby adding the promising bone-marrow cancer treatment pelabresib to its pipeline. Second, it announced the acquisition of Mariana Oncology for US$ 1 billion upfront (plus US$ 750 million in milestone payments), thereby expanding into radioligand therapies (RLTs) to treat cancers with high unmet need. RLTs take a targeted approach, delivering radiation to the tumor, while limiting damage to the surrounding cells.AstraZeneca entered the field of radioconjugates, which is a promising modality in the treatment of cancer, by acquiring Fusion Pharmaceuticals for US$ 2.4 billion.In January this year, Johnson & Johnson had announced the acquisition of antibody-drug-conjugate (ADC) developer Ambrx Biopharma for about US$ 2 billion. With this buyout, J&J has joined the likes of Bristol Myers Squibb, AbbVie and GSK who had entered this promising field through acquisitions last year.Similarly, Denmark’s Genmab bought ProfoundBio for US$ 1.8 billion in cash, boosting its oncology portfolio with three next-generation ADC candidates. This includes Rina-S, which recently received FDA’s fast track designation for the treatment of ovarian cancer.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available)  Novartis signs multiple collaborations; GSK, Takeda, AbbVie sign billion-dollar dealsNovartis was not just busy signing M&A deals, it also signed a bevy of collaboration agreements. For instance, Shanghai-based Argo partnered Novartis on two early-stage RNA interference candidates for cardiovascular diseases, potentially earning the former up to US$ 4.2 billion plus tiered royalties.Novartis also agreed to pay up to US$ 3 billion (including US$ 150 million upfront) to Dren Bio to use the latter’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies to treat cancer.Moreover, the Swiss drugmaker expanded its peptide discovery collaboration with Japan-based PeptiDream in a deal worth over US$ 2.71 billion in milestone payments, plus an upfront payment of US$ 180 million. Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutic drugs after ADCs and Novartis is, thus far, the only big pharma with FDA-approved radioligand PDCs. GSK entered a groundbreaking partnership with Flagship Pioneering, potentially worth over US$ 7 billion, to identify and develop 10 novel drugs and vaccines. The deal, starting with respiratory and immunology drugs, involves US$ 720 million in upfront and milestone payments for each candidate. This collaboration leverages Flagship’s extensive portfolio of over 40 biopharma companies with drug development capabilities.There were two significant deals in the field of neuroscience. First, Takeda said it is paying Swiss biotech AC Immune US$ 100 million upfront with potential further payments of US$ 2.1 billion for an exclusive option to license global rights to an Alzheimer’s vaccine and related immunotherapies.Second, AbbVie and clinical stage biotech Gilgamesh Pharmaceuticals joined forces in a deal potentially worth over US$ 2 billion to develop a new class of psychedelic compounds for psychiatric conditions, combining AbbVie’s psychiatric expertise with Gilgamesh’s innovative neuroplastogen research platform.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available)  Our viewDuring this year, companies like Novartis (with US$ 16.8 billion), GSK (US$ 14.5 billion), Sanofi (US$ 11.9 billion), Bristol Myers Squibb (US$ 11.6 billion), and AbbVie (US$ 9.1 billion) have made substantial investments in acquisitions, collaborations and other forms of dealmaking.Though the deal-making environment is robust, we notice a shift towards mid-size transactions. Alongside, we notice a growing interest in areas such as ADCs, radiopharmaceuticals, and protein-based immunotherapies, underscoring their growing importance in drug development. There has also been significant interest in silencing RNA (siRNA) therapeutics, highlighting the industry's focus on novel approaches to disease treatment. With the industry focusing on cutting-edge technologies that address unmet medical needs, we feel there is little reason to fret over the size of the deals.  
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    22 Aug 2024
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    FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options

    FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options

    The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023.  Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel mechanism of action and is the first inhaled maintenance treatment for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on July 2 after an FDA advisory committee voted unanimously in favor of its benefits outweighing its risks. To be sold as  Kinsula, the Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin earlier this month and has requested information related to the manufacturing process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva (nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain cancer. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor, including fusions. Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung cancer (SCLC) that has proven to be hard to treat or has worsened despite platinum-based chemotherapy. Imdelltra is expected to bring in annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from Basilea, Merck, rare disease med from Ipsen bag  approvalsAfter oncology, infections and infectious diseases, and rare diseases were the two therapeutic areas that saw the second and third most approvals, respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic for bacterial infections including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by the syncytial virus. This is the first non-Covid mRNA vaccine to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary biliary cholangitis (PBC), a rare liver disease. This is the first new medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic leukodystrophy (MLD). The debilitating hereditary disease affects the brain and the nervous system and causes loss of cognitive and motor functions and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024. 
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    25 Jul 2024
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    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  
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    11 Jul 2024
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    FDA approves record eight biosimilars in H1 2024; okays first interchangeable biosimilars for Eylea
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