The Covid-19 pandemic expedited the
growth of contract development and manufacturing organizations (CDMOs) as
pharma companies increasingly turned to them to accelerate drug development.
However, by the end of 2022, a decline in demand for
Covid vaccines hit some CDMOs, and they saw their supply deals come to an
abrupt end.The year 2022 also saw the steepest drop
in new drug approvals by the US Food and Drug Administration (FDA) since 2016.
Although the Center for Drug Evaluation and Research (CDER) only approved 37 new drugs, a 26 percent decline from the 50 drugs approved in 2021, there was a rise in new biologic drug approvals. Of these, 41 percent were biologics. Eight biologics were also approved by FDA’s Center for Biologics Evaluation and Research
(CBER) in 2022.Despite other challenges like high inflation, the ongoing Russia-Ukraine war and increasing economic uncertainties, CDMOs continued to grow through 2022 and the first quarter of 2023, particularly in biologics, cell and gene (C&G) therapies and highly potent active pharmaceutical ingredients (HPAPIs).CDMOs have been swift in altering their
production lines to meet the demands of smaller, more diverse projects. This
flexibility is likely to contribute to future growth. According
to Research and Markets, the global
CDMO market was valued at US$ 172.7 billion in 2022, and is projected to reach US$ 246.6 billion by 2026, growing
at a CAGR of 9.3 percent.View CDMO Activity Tracker of Q1 2023 (Free Excel Available)Large
CDMOs post double-digit growth; Sartorius buys Polyplus for US$ 2.6 billionSeveral big CDMOs such as the Lonza Group, Samsung Biologics and Siegfried AG reported impressive revenue
growth in 2022. Switzerland-based Lonza, the biggest CDMO player, saw its
revenue grow 15 percent to reach CHF 6.2 billion (US$ 6.7 billion) in 2022.Samsung Biologics’ CDMO revenue skyrocketed 49 percent in 2022, as compared to 2021, touching KRW 2.34 trillion (US$ 1.85 billion). Siegfried generated CHF 1,229 million (US$ 1.33 billion) in sales, a growth of 15.6
percent. And EUROAPI’s CDMO business grew 18.3 percent to reach € 267.5 million (US$ 0.28 billion). Meanwhile, Pfizer CentreOne generated US$ 1.34 billion in sales in 2022. As demand for Covid jabs dropped, Catalent announced structural changes and
cost-reduction measures, including more than 210 layoffs at
its Texas and Maryland facilities. It also laid off up to 400 employees at its Bloomington, Indiana site. Overall, Catalent’s revenues grew by 1 percent — at US$ 2.17 billion — in the last six months of 2022. Similarly, UK-based CDMO Abzena also laid off 66 employees in
San Diego.So far, the biggest CDMO deal of 2023 has
been the acquisition of France-based Polyplus, a provider of innovative upstream technologies for advanced biologic and C&G therapy production, by Germany-based CDMO Sartorius Stedim Biotech for €2.4 billion (US$ 2.6 billion). The deal gives Sartorius the know-how needed in the production of viral vectors for building C&G therapies.View CDMO Activity Tracker of Q1 2023 (Free Excel Available) Catalent
expands into cell therapies, Charles River Labs signs deal with RznomicsThe development of C&G therapies has emerged as a high growth
area for CDMOs. In 2022, CSL’s hemophilia B treatment Hemgenix emerged as the world’s most expensive medicine,
beating Bluebird bio’s C&G therapies — Skysona and Zynteglo. This year, around 13 C&G therapies are expected to receive approval in the US and Europe, offering big opportunities to CDMOs worldwide. The US$ 3.2 billion CDMO market for C&G therapies is estimated to be growing at 18.1 percent CAGR, and is poised to reach US$ 18.6 billion by 2032.In January, Catalent opened a new plasmid
DNA manufacturing facility in Belgium for cell therapies and expanded its partnership
with Sarepta for manufacturing its gene therapy candidate — SRP-9001. If approved, this could be the first gene therapy for Duchenne muscular dystrophy
(DMD). Catalent has also entered into a licensing agreement with Bhami Research Laboratory to access the latter’s formulation technology to help enable the subcutaneous delivery of high-concentration biologic therapies.Charles River Laboratories has signed a deal with
South Korean biopharma Rznomics to develop and manufacture viral
vectors for a gene therapy to treat liver cancer. It also inked another deal
with Purespring Therapeutics for plasmid DNAs and acquired SAMDI Tech for US$ 50 million. In recent years, the company has expanded its C&G portfolio through the acquisitions of Cobra Biologics, Vigene Biosciences and Cognate BioServices.View CDMO Activity Tracker of Q1 2023 (Free Excel Available) Samsung
Biologics, LOTTE, Lonza expand facilities for ADCsThe other emerging growth area for CDMOs
is biologics. The global CDMO market for biologics was valued at US$ 11.27 billion in 2021 and is expected to grow at 11.51 percent CAGR to reach US$ 21.90 billion by 2027. Technological advancements and approval of new biologic drugs is contributing to this growth.Biologics are triggering deals. After Provention Bio received FDA approval for its
type 1 diabetes drug Tzield last year, the US-based company
signed a deal with AGC Biologics in January this year to produce
the drug at its Seattle biologics plant. Last month, Sanofi announced it is acquiring
Provention Bio for US$ 2.9 billion.Several CDMOs are also vying for a share
of the fast growing antibody-drug conjugates (ADC) market, which is projected
to reach US$ 13.1 billion by
2030, up from US$ 3.51 billion in 2020. Samsung Biologics’ CEO, John Rim, announced in
January that ADCs would be a major focus area for the company. It is investing US$ 1.46 billion to construct its plant 5 for
biopharmaceuticals and plans to start operations in 2025. It has also entered
into a manufacturing deal with Pfizer for US$ 183 million.Newly-established CDMO LOTTE Biologics is also expanding its
facility for
ADCs in order to get a foothold in North America. LOTTE Biologics plans to invest US$ 3 billion
over the next seven years to build three mega plants. It has also acquired BMS’ manufacturing facility in New
York for US$ 160 million. Similarly, Lonza completed the expansion of
its facility for ADCs in Visp, Switzerland.View CDMO Activity Tracker of Q1 2023 (Free Excel Available)Growing
demand for HPAPIs, controlled substances draw investments in CDMOsThe global market for HPAPIs is growing
at 8.5 percent CAGR and is expected to reach US$ 34 billion in
2026. Several companies have announced expansion plans to meet this rising demand.Piramal Pharma Solutions has started production of APIs and HPAPIs at its
facility in Michigan, US. German CDMO ChemCon provides services for APIs,
HPAPIs and controlled substances, including amphetamines, cannabinoids, fentanyl derivatives and steroids. Additionally, it offers high-quality fine chemicals, isotopically labeled compounds, organic, inorganic and polymer chemistry. Its products are used for important specialty applications such as oncology, orphan diseases, critical care, dermatology, etc. Veranova’s subsidiary Macfarlan Smith has
completed a US$ 10 million expansion
of its mid-scale API manufacturing capabilities in Edinburgh, UK. Siegfried has opened a development center for
drug products in Barcelona, Spain, with dedicated facilities for HPAPI
products. Last November, Polpharma announced investment at its HPAPI facility in Poland. It expects to open a new R&D and production facility in the first quarter of 2024. Meanwhile, Eurofins CDMO Alphora Inc has also expanded its API development laboratories, including those for HPAPI development.CDMOs are also expanding their services
for controlled substances, particularly in therapeutic areas such as
depression, PTSD, addiction and pain management. Due to stringent regulations
on the development and manufacture of controlled substances, pharma companies
are turning to CDMOs that are experienced and licensed to handle them. These
include Cambrex Corporation, Curia, Patheon, Pfizer CentreOne, Veranova, ChemCon, Evonik, Minakem and Seqens.View CDMO Activity Tracker of Q1 2023 (Free Excel Available)Our
viewOver the last few years, we have noticed
how CDMOs have altered their business models with changes in the business
environment. Of late, CDMOs have benefitted from the trend of smaller biotechs outsourcing manufacturing of novel modalities, such as C&G and RNA therapies. Of the 37 drugs approved by the FDA’s CDER last year, 24 (or 65 percent)
were developed by mid or small-sized biopharma companies.We also know how the approval of new drugs benefits
the CDMO industry. For instance, FDA approved Rigel Pharma’s Rezlidhia (olutasidenib) in December as a treatment for relapsed and refractory acute myeloid leukemia. The drug’s dose manufacturing has been outsourced to Catalent. Therefore, a rise in the approval of novel drugs in 2023 should benefit the industry. And rapid advancements in biotechnology will ensure healthy growth of CDMOs.
Impressions: 2798
GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal
This week,
Phispers brings to you the details of the bioelectronics firm formed by GSK and
Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli
Lilly, besides two other news snippets pertaining to the FDA -- while the first
one pertains to generic approvals, the other one relates to an additional black
box warning on a few antibiotics. GSK and Google
join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life
Sciences and GSK will together contribute US $ 715.12
million
over seven years to the startup Galvani Bioelectronics. The startup will develop
miniature electronic implants for the treatment of asthma, diabetes and other
chronic conditions. The
implantable devices developed by Galvani, which is owned 55 percent by GSK and
45 percent by Verily, can modify electrical nerve signals. The aim is to
modulate irregular or altered impulses that occur in many illnesses.The
new company
will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK
has been working on bioelectronic medicines since 2012 in a push to develop new
patentable treatments, since its Advair respiratory treatment faces competition
from generic versions. It has invested US $50 million in a venture capital fund
for bioelectronics and provided funding to scientists working in the field. Teva divests 79
products to 11 generic players to close Allergan dealTeva
Pharmaceutical Industries – the world’s largest generics drug company – won a US
anti-trust approval to purchase Allergan's generics
business, after agreeing to divest 79 generic drugs to rival firms. This was arrived
at to settle Federal
Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The
companies that
have acquired
the divested products are Mayne Pharma
Group, Impax
Laboratories, Dr Reddy’s Laboratories, Sagent
Pharmaceuticals, Cipla Limited, Zydus Worldwide
DMCC, Mikah Pharma, Perrigo Pharma
International, Aurobindo
Pharma USA,
Prasco and 3M Company. Eli Lilly CEO
steps down; company under probe by US Justice Department Eli Lilly CEO John
Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter
has been the company's CEO since April 1, 2008, and the chairman of its board
of directors since January 1, 2009.The
announcement has come at a time when Eli Lilly has been asked by the
Justice Department to disclose information on relationships with pharmacy benefits
managers (PBMs), the companies that negotiate prices and set reimbursement
conditions.It
has not been clear what exactly the department of justice is looking for. In
the past, drug makers such as Novartis and AstraZeneca have agreed to
pay fines and penalties to settle allegations pertaining to PBMs. FDA continues
to race ahead with generic approvals The
American regulator has reduced its pile of ANDA (abbreviated new drug
applications) by about 500
applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This
news comes after Bloomberg reported
last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass
had reported last week that Indian
companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark In
regulatory news from across the world, Jinan Jinda, a Chinese API
manufacturer that had failed an inspection by Italian regulators in June 2015,
had more bad news awaiting it a year on. In
a June 2016
re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In
the June 2015 inspection, the critical observation was related to an unofficial
and non-controlled storage area containing mainly raw materials and finished
products which had been made
inaccessible to inspectors as the door had been removed and replaced with a panel fixed with
screws to the wall.Meanwhile,
the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy
immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements. Another black
box warning added to antibiotics like Cipro and LevaquinThe
FDA has upgraded
warnings on
certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro
extended-release tablets and Merck’s Avelox. The FDA had
added a black box warning in 2008 about the increased risk of tendinitis in
which the tissue connecting muscle to bone becomes inflamed. In
May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated
infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to
overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has
said it plans to build a new pipeline of drugs. It plans to revamp its
research operations at the cost of around US $ 727 million.. The
company also plans to close some of its R&D operations in the UK. Takeda is
beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement.
Impressions: 2760
Every quarter, PharmaCompass compiles the latest Drug Master Files (DMFs) submitted to the US Food and Drug Administration (FDA). These applications provide an overview of products which active pharmaceutical ingredient (API) manufacturers are investing their resources in and also give a sneak preview into the next possible first-to-file (FoF) generic challenges to patented drugs. Here are the key findings from the compilation for the first
quarter of 2016: Compliance problems
aside, India tops the DMF submissionsIf news about compliance problems faced by pharma companies
in India and China are making you believe that there is a slowdown in these
countries, think again. A total of 190 DMF submissions were made in the first
quarter of 2016, up from 180 in the previous quarter. And over two-thirds of
the submissions were for products from facilities based in either India or
China with more than 100 filings from India alone. Companies that have been on the compliance radar recently – such as Ipca
Laboratories, Emcure
Pharmaceuticals, Minsheng
Group Shaoxing Pharmaceutical and Yincheng Goto – also made submissions to the FDA. Besides these, Qilu
Pharmaceutical, which was in the news recently for the controversy in China
involving school children, also submitted its DMFs this quarter. Teriflunomide leads DMF
race; Carfilzomib is the new molecule on the blockLast quarter, Teriflunomide saw the maximum number of DMF submissions – four. This quarter too, Teriflunomide led the pack with maximum submissions – six. This is an indication that Sanofi’s
multiple sclerosis drug will be subject to severe competition in the coming
future.Amgen acquired Onyx
Pharmaceuticals for US $ 10.4 billion in 2013 primarily to cash in on the potential of Kyprolis
(carfilzomib), a cancer-treatment drug. While analysts had estimated peak sales of US $ 1.6 billion as a result of this acquisition, sales in 2014 turned out to be only US $ 331 million – a fifth of their estimates. However, things looked up in 2015 as Kyprolis brought in US $ 512 million in sales. Amgen needs to quickly capitalize on the opportunity as six more DMFs were submitted this quarter, indicating a severe generic onslaught whenever the drug goes off patent. Enzalutamide has been in news recently as Medivation, the US
cancer drug company that discovered the molecule, has finally become open to a
sell-off after Sanofi offered US $ 9.3 billion to buy the cancer drug
maker. Even as Sanofi tries to acquire Medivation, generic activity is underway
with three more DMF submissions this quarter. MSN Labs leads the FoF
challenges and filingsMSN Laboratories may not be well-known in the Indian pharmaceutical industry, but the company is growing from strength to strength each quarter with its capabilities of developing non-infringing routes for APIs and being one of the first companies to submit DMFs.This quarter, MSN
Laboratories and its subsidiaries submitted 20 DMFs, which is more than 10 percent of all applications filed. MSN’s filings include Apremilast
(Celgene’s Otezla), Bosutinib
(Pfizer’s
Bosulif), Macitentan
(Actelion’s
Opsumit) and Vortioxetine
Hydrobromide (Takeda’s
Brintellix) Innovative filings In
the worksBiotin, a water soluble Vitamin B, is claimed to aid nail and hair growth. If French biotech startup -- Medday Pharmaceuticals – succeeds in its Phase III trials, its lead product MD1003, a pharmaceutical grade
D-Biotin, would improve the lives of patients suffering from progressive
multiple sclerosis (MS).MedDay and DSM Nutritional Products had earlier announced a
partnership and co-investment for manufacturing pharmaceutical grade D-Biotin.
This quarter DSM submitted its DMF for Biotin.Switzerland-based biopharmaceutical company Debiopharm’s
Salvacyl®, Moapar® has been used mainly for the treatment of prostate cancer. Now, armed with a new indication, the three-month formulation of triptorelin – which has been registered in several European countries to treat severe sexual deviation in adult men (for instance, paedophilia) – saw a DMF submission this quarter indicating a potential launch of this product in the US.Dimethyl fumarate (Biogen’s Tecfidera) led
the list of DMF filings last quarter as the brand product generated sales of US
$ 3.64 billion in 2015 and is projected to achieve US $
5.56 billion by 2020. While generic companies have been targeting Dimethyl Fumarate, Hyderabad-headquartered
Honour Labs – a company promoted by Dr B Parthasaradhi Reddy
who is also the promoter of generic major Hetero Drugs – filed a DMF for Monomethyl Fumarate. It would be interesting to see if this minor tweaking in the
molecular structure could lead to a windfall gain for Hetero. Our viewWith drug filings ranging from cannabis extract to amphetamines
to generic paracetamol,
the first quarter of 2016 displayed that the API industry is extremely active
with new product development. You can view the PharmaCompass
compilation of the new DMF filings by clicking here or simply by sending us an
email to get your own Excel version of the new submissions.
Click here to view all the submissions of the first quarter of 2016 (Excel version available) for FREE!
Impressions: 5250
Teva Pharmaceutical Industries, Ltd., which acquired Cephalon in 2012, will make a total payment of $1.2 billion as part of a ‘pay-for-delay’ settlement reached with the Federal Trade Commission (FTC) last week.
What exactly did Cephalon, for which Teva paid $6.8 billion, do so wrong? Isn’t ‘pay-for-delay’ common practice in the pharmaceutical industry?
First of all what is a
pay-for-delay?
‘Pay for delay’ or reverse payment patent settlements, are agreements where the brand name drug manufacturer compensates generics, not to market the generic product for a specific period of time.
These settlements allow the brand manufacturers to extend their
patent monopolies and according to an FTC study, these deals
cost consumers and taxpayers $3.5 billion in higher drug costs every year.
What exactly happens and
why is it a big deal now?
Cephalon allegedly paid four generic drug companies (Teva, Ranbaxy Pharmaceuticals, Mylan Pharmaceuticals, and Barr Laboratories), over $300 million in total. In return the generics agreed to drop their patent challenges and forgo marketing of their generic versions of Cephalon’s blockbuster sleep-disorder drug Provigil, for six years, until April 2012.
An extended monopoly for Provigil, in the absence of generic competition, was “$4 billion in sales that no one expected”, the CEO of Cephalon reportedly said when the deal was struck.
While in Europe, regulators have been going after pay-for-delay cases for years, it was only as recently as 2013, in FTC v. Actavis, that the U.S. Supreme Court made clear that reverse payment patent settlements are subject to the same antitrust rules that govern general U.S. business conduct.
The payment made by Teva will compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct, is the first positive outcome for the FTC after the Supreme Court ruling.
How common are ‘pay-for-delay’ settlements?
Based on data provided by the FTC, for the past few years, more
than 100 settlements are reached annually between brand and generic
pharmaceutical companies.
Over 30% of these settlements have the potential of being ‘pay-for-delay’ agreements.
Table// Potential
pay-for-delay settlements reached between brand and generic companies:
Financial Year
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
Final Settlements:
between brand and generic companies
14
11
28
33
66
68
113
156
140
145
Involving First Generic Filing
8
5
11
16
29
32
49
54
43
41
Potential Pay-for-Delay:
Involving First Generic Filing
2
9
11
13
15
26
18
23
13
Settlements
3
14
14
16
19
31
28
40
29
How severe are the penalties for ‘pay-for-delay’ settlements in Europe?
The European Commission has
fined Johnson
& Johnson (J&J) just under 10.8 million
euros and Novartis 5.49 million euros, after discovering a ‘pay-for-delay’ deal on the painkiller Duragesic (fentanyl).
The amount pales in comparison to
the whopping €428m fine on Servier and several other companies (Niche/ Unichem; Matrix, which is now part of Mylan; Teva; Krka and Lupin) for conspiring to delay generics of the widely-used blood pressure drug Coversyl/ Aceon (perindopril).
In yet another settlement, agreements which operated in 2002 and
2003 between the Danish originator Lundbeck, and other
generic companies, resulted in Euro
146 million in fines.
What should we expect in the future?
Based on an FTC
presentation made in September 2014, they highlighted 19 Cases to Watch, which has them targeting almost every
major brand and generic pharmaceutical company. However, with the complexities
involved, this list is continuously evolving:
The
cases (by name of the brand product) Actos,
Adderall,
Aggrenox,
AndroGel,
Cipro,
Effexor,
K-Dur, Lamictal, Lidoderm,
Lipitor,
Loestrin,
Nexium,
Niaspan,
Opana,
Provigil,
Skelaxin,
Solodyn,
Wellbutrin.The
brand companies involvedAbbvie,
Abbott,
AstraZeneca,
Bayer,
Besins,
Biovail,
Boehringer,
Cephalon,
Endo,
GlaxoSmithKline,
King,
Medicis,
Pfizer,
Shire,
Schering,
Takeda,
Warner
Chilcott, Wyeth.The
generic companies Actavis
, Barr,
Duramed,
Dr. Reddy’s, HMR, Impax,
Lupin,
Mutual,
Mylan, Par, Perrigo,
Ranbaxy,
Rugby, Sandoz,
Teva,
Upsher
Smith.
Our view:
Pharmaceutical companies,
lawyers and the FTC will be busy for the coming few years, since there are a
series of suits, which will be challenging settlements reached between brand
and generic pharmaceutical companies.
While patents
provide temporary monopolies to promote innovation, brand drug manufacturers
will need to resort to more innovative ways of sustaining their profits.
Click here and learn about the different strategies adopted in the United States to block generics?
Impressions: 3402