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    DMF submissions in 2021: India, China continue to top filings

    DMF submissions in 2021: India, China continue to top filings

    The year 2021 was eclipsed by the Covid-19 pandemic. In our update for the first half of 2020, we had mentioned that Covid-19 has not slowed down the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). That trend continued in 2021, when the speed of DMF submissions to the agency remained similar to that witnessed in the previous years. In fact, Type II DMFs, or DMFs for active pharmaceutical ingredients (APIs), were higher in 2021 as compared to previous years. In the first quarter, FDA received 164 Type II DMF submissions, which rose to 165, 166 and 172 submissions over the next three quarters. In all, 667 Type II DMFs were filed in 2021, as opposed to 662 in 2020, 633 in 2019 and 644 in 2018. DMFs are submissions made to the FDA by manufacturers who provide the agency with confidential, detailed information about facilities, processes or articles used in manufacturing, processing, packaging and storing of human drug products. Overall, 2021 saw a total of 913 DMFs (Type II, III, IV and V) being submitted. In comparison, FDA had received 931 DMF submissions in 2020, 894 in 2019 and 979 in 2018. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) India continues to lead DMF filings, followed by China Country-wise data on DMF filings at the FDA tells us the potential of a country in the field of pharmaceuticals. At the company-level, with each DMF filing, a firm commits itself to manufacturing drugs in a facility that is aligned to the FDA’s rules and regulations. This year too, DMFs filed from India and China were significantly higher than those from other countries. Expectedly, India continued to lead with 376 DMF filings. Submissions from India were over twice that of DMF filings from China (at 159). This is not surprising since the two countries have the maximum number of API manufacturing facilities registered with the FDA. As compared to this, the United States had 52 DMF filings, Italy had 10, Spain and Taiwan had 9 each, and countries like Canada, Israel, Japan and UK had five DMF filings each. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) India’s MSN Labs leads DMF count As in the past, India's MSN Laboratories continued to lead the DMF filings by a single company with 43 submissions. MSN was followed by five other Indian companies — Dr. Reddy’s Laboratories filed 15 submissions, Hetero Group and Aurobindo Pharma 14, Metrochem API 13 and Aurore Life Sciences filed 12 DMF submissions. The only Chinese company in the top 10 by DMF count was Brightgene Bio-Medical Technology Limited with nine DMF submissions. The maximum number of DMF filings were for semaglutide (eight), followed by favipiravir (seven), apalutamide (six), sitagliptin phosphate (six) and tofacitinib citrate (six). Others like acalabrutinib, elagolix sodium, lenalidomide, liraglutide and pantoprazole sodium had five DMF filings each. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) Slow assessment review, higher GDUFA fee Although there were 667 Type II DMFs filed with the FDA, only 194 (or 29 percent) had their review completed. The GDUFA (short for Generic Drug User Fee Amendments) fee associated with a DMF assessment review for 2021 was considerably higher — at US$ 69,921 — as opposed to US$ 57,795 for 2020. For FY 2022, the GDUFA fee has been revised upward to US$ 74,952 (an increase of US$ 5,031).  There are 42 products for which a DMF was filed for the first time. Among the patented products which should expect generic competition are avatrombopag, encorafenib, esketamine hydrochloride, siponimod fumaric acid, tedizolid phosphate and vorapaxar sulfate. In fact, DMFs were also filed for products that are yet to receive an FDA approval. Some of these products are imeglimin, aviptadil, gimeracil, linzagolix choline, meglumine antimoniate, roluperidone hydrochloride and teneligliptin. View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) Our view The Covid-19 pandemic revealed how the global supply chain for pharmaceuticals is excessively dependent on India and China. As a result, many countries across the world are making investments into expanding their API production capacities. This should translate into more Type II DMF filings from countries other than India and China. Moreover, as the pandemic begins to wane and the FDA increases its inspections — both domestic and international — compliance issues are bound to increase. The US is planning to run a pilot program soon that will test a system of unannounced inspections in India and China. Companies in both India and China will need to increase their focus on compliance if they wish to continue to be major contributors to the global supply chain for pharmaceuticals. We can certainly expect more regulatory news in 2022.View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available) 

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    https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-in-2021-india-china-continue-to-top-filings

    #PharmaFlow by PHARMACOMPASS
    17 Feb 2022
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    Sales Forecast of FDA’s Novel Drugs Approvals in 2018

    Sales Forecast of FDA’s Novel Drugs Approvals in 2018

    The year 2018 was a landmark year for the US Food and Drug Administration (FDA) as the agency approved a record number of novel drugs. FDA approved 62 novel drugs in 2018, out of which 34 were orphan drugs. FDA’s Center for Drug Evaluation & Research (CDER) approved 59 drugs while the other three were approved by the Center for Biologics Evaluation and Research (CBER). In a speech towards the end of the year, FDA Commissioner Scott Gottlieb said: “Far more important than the overall quantity of approvals however is the quality of the new drugs”. He went on to add that some “of [the] previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines,” or novel chemical entities that addressed the same common, therapeutic targets. In 2018, FDA reversed three earlier drug rejections, approved the first cannabis-based drug, allowed the first ever RNA interference drug to market and gave the green light to Loxo Oncology/Bayer’s Vitrakvi (larotrectinib) which became the second anti-cancer drug (after Merck’s Keytruda) to bag an approval that treats cancer based on a biomarker across different types of tumors rather than the location in the body where the tumor originated. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Gilead’s Biktarvy tops our list for sales potential   PharmaCompass compiled the peak sales estimates of the new drugs approved in 2018 and in our compilation, Gilead’s antiretroviral treatment for HIV — Biktarvy — topped the charts with an estimated sales potential of almost US$ 5.3 billion followed by Vertex’s cystic fibrosis drug Symdeko that is expected to bring in US$ 2.75 billion. Alexion’s Ultomiris, Abbvie’s Orilissa, Novartis’ Lutathera and J&J’s Erleada are all expected to bring in more than US$ 2 billion for their companies at their peaks.  Although Loxo’s cancer drug, with an estimated US$ 860 million in peak sales, did not make it to the list of top 15 drugs in 2018 by sales potential, the company got purchased by Eli Lilly earlier this month for US$ 8 billion. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Pfizer won four approvals, Shire won three   For 2018, Pfizer led the approvals with four drugs that got the green light, followed by Shire with three drugs. Companies like AstraZeneca, Array Biopharma, Alynlam and Paratek Pharmaceuticals each won two drug approvals. Merck also had two approvals which were in cooperation with other companies. Amgen, Teva and Eli Lilly got their CGRP inhibitors for migraine prevention approved within a few months of each other. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 First cannabis-based drug bagged approval   Last year, FDA also approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome.  CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. And Epidiolex is the first marijuana-based drug to be approved in the US for epilepsy. It is produced by GW Pharmaceuticals. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 CBD does not cause intoxication. It is one of the hundreds of molecules found in marijuana and has been cited by scientists as a potential treatment for mental health issues. 2018 saw the launch of one-dose flu cure from Shionogi   In March 2018, Shionogi & Co Ltd.’s Xofluza — a pathbreaking drug that cures flu with just one dose — was approved in Japan. The drug is a treatment for influenza A and influenza B.  In October, the US Food and Drug Administration (FDA) also approved Xofluza (baloxavir marboxil). Xofluza is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 The single dose feature gives Xofluza an edge over other neuraminidase inhibitors like Tamiflu and Relenza. For example, Tamiflu typically requires two doses each day for five days. Therefore, there are nine more doses of Tamiflu required, as compared to the single-dose Xofluza. Shionogi aims to double the global market for flu treatment with Xofluza. “While the global market of flu drug is said to be about US$ 1 billion to US$ 1.5 billion, we want to expand it to around US$ 3 billion,” Shionogi CEO Isao Teshirogi said last year. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Though the FDA approval for Xofluza has been granted to Shionogi, Genentech (a member of the Roche Group which marketed Tamiflu, which is now a generic) will be marketing the medication in the US. Industry gets far lower returns from its drug launches   Gottlieb used Twitter to promote the progress of FDA’s review cycle. “In 2018, CDER met its PDUFA goal for 100 percent of the novel drugs approved – 95 percent of which on the first cycle – reflecting our efficiency in getting new therapies to patients quickly,” he tweeted. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 A ‘cycle’ is the time from when CDER accepts an application for a new drug until the agency decides whether to approve it or not. However, the record number of approvals doesn’t present the complete picture for the pharmaceutical industry. A study published in December by Deloitte highlighted that the industry is getting far lower average returns from its drug launches than ever before. While the costs to bring a drug to market have almost doubled in eight years to over US$ 2 billion, peak sales forecasts have halved to a little over US$ 400 million, the study said. Drug discovery reviews in the scientific publication Nature reached a similar conclusion. “Projected peak annual sales for new therapeutic drugs (NTDs) approved in 2018 total US$ 45 billion — lower than 2017’s US$ 58 billion — and the value of the average peak sales per product has continued to trend down to only US$ 720 million per drug in 2018, the lowest figure in almost a decade,” the publication said. “The decline is driven both by fewer blockbusters at the top end, as well as a proliferation of very small products at the bottom end. We believe the underlying driver of both these trends — more approvals but smaller markets per approval — is better understanding of biology fostering precision medicine,” it added. Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018 Our view   After suffering brutal losses towards the end of 2018, wherein biotech was among the US stock market’s most oversold sectors and saw a decline of nearly 10 percent, this year the biotech sector has got off to the best start since 2012. Drug companies are continuing to innovate more targeted therapies, and Chinese companies are investing in developing new drugs. While the industry expects to see a lot more mergers and acquisitions in 2019, where smaller biotech companies get acquired by major pharmaceutical corporations, it is unlikely that the general trend of companies bagging more approvals for targeted therapies with a smaller peak sales potential is going to reverse anytime soon.  Click Here to View the Sales Forecast of FDA's Novel Drug Approvals in 2018  

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    https://www.pharmacompass.com/radio-compass-blog/sales-forecast-of-fda-s-novel-drugs-approvals-in-2018

    #PharmaFlow by PHARMACOMPASS
    17 Jan 2019
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