Monday, April 29, 2024

11 Drugs Now in Shortage

(4/26, Paige Twenter, Becker's Hospital Review) ...Here are 11 new shortages, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists...Hydroxocobalamin injection: One solution of the anemia drug is in shortage at Teva Pharmaceuticals because of testing delays. Supply is expected to rebound in late April. Isosorbide mononitrate immediate-release tablet: Teva, the sole supplier of the heart failure medication, has its product on back order and expects to release supply between April and May... Full

Coming to a CVS Near You: A Store Brand Monoclonal Antibody

(4/29, David Wainer, The Wall Street Journal) ...Store brands are more profitable for them because they offer higher margins. Now CVS is deploying that same approach to the much more profitable business of blockbuster prescription drugs. The move already seems to be paying off and spreading to other managed care organizations, like Cigna Group, with major repercussions for manufacturers of lower-cost biosimilar products. These are cheaper versions of biotech drugs made from living cells, which are far more complicated to make than traditional pills... Sub. Req'd

Celltrion's Zymfentra Included in Express Scripts' Preferred Formulary in US

(4/29, Lee Han-soo, Korea Biomedical Review) ...Celltrion has unveiled a partnership with Express Scripts, one of the top three pharmacy benefit managers in the U.S., for its subcutaneous Remicade biosimilar, Zymfentra, on Monday...The company believes the partnership will enhance Celltrion's mission of broadening the reach and value of its FDA-approved products through ongoing collaborations with national and regional health plans, PBMs, and group purchasing organizations... Full

…And Amgen Makes Three: Another Ustekinumab Biosimilar Gets Go-Ahead In EU

(4/26, David Wallace, Generics Bulletin) ...Amgen has become the third firm to win a positive opinion from the European Medicines Agency for a Stelara (ustekinumab) biosimilar, after its Wezenla version was endorsed by the agency's Committee for Medicinal Products for Human Use in its April meeting...The first two ustekinumab biosimilars – Alvotech and Stada's Uzpruvo, and Samsung Bioepis and Sandoz's Pyzchiva – have both now seen their positive opinions converted into final approvals. Launches are expected imminently, with Alvotech and Stada having pointed to a likely July introduction following the expiry of a European supplementary protection certificate covering Stelara... Global Sub. Full

Amneal Launches Ready-To-Use Pemetrexed And OTC Naloxone

(4/26, Urte Fultinaviciute, Generics Bulletin) ...Amneal marked its first 505(b)(2) product launch of the year as the firm's first and only ready-to-use Pemrydi RTU (pemetrexed) hit the US market. Pemrydi received a US Food and Drug Administration approval in June 2023, with a then-expected launch date in Q1 2024. However, the firm hinted about an April launch date during its Q4 and full-year 2023 earnings call last month... Global Sub. Full

AbbVie Beats First-Quarter Expectations, But Humira Guidance Leaves Analysts Confused

(4/26, Max Gelman, Endpoints News) ...On Friday, the company announced a 40% decline in the megablockbuster drug's US sales for the first quarter. While it managed to hang onto the vast majority of market share, AbbVie did so by offering substantial discounts to compete with the biosimilars that have flooded the market. While the drop in Humira sales — which made up 18.4% of AbbVie's worldwide revenue in the first quarter — was better than Wall Street analysts had projected, the company will face far stiffer competition this quarter... Full

Drugmaker AbbVie Expects Humira Volume Erosion to Worsen

(4/26, Leroy Leo and Christy Santhosh, Reuters) ..."What we see is that not all of the Humira prescriptions are moving to a biosimilar," Chief Commercial Officer Jeffrey Stewart said during an investor conference call. He said data showed patients were also moving to other drugs such as AbbVie's newer immunology treatments Skyrizi and Rinvoq...Health insurer Cigna said on Thursday it plans to make close copies of Humira available with no out-of-pocket payment to eligible patients in the U.S. using its specialty pharmacy business beginning in June. "There seems to be a lot of concern around the impact of Humira biosimilars. That seemed to be a focus on the call with most of the questions centering around this," BMO Capital Markets analyst Evan Seigerman said, adding that Cigna's plans could hit AbbVie's Humira volume this year... Full

No Takers For Biogen's Biosimilars Business?

(4/26, David Wallace, Generics Bulletin) ...While naming no names, rumored buyers have included the likes of longtime Biogen partner Samsung Bioepis; Indian giant Intas; and burgeoning biosimilars player Dr Reddy's. But Biogen's latest results call suggested that all of the interested parties that had engaged with Biogen had failed to meet the firm's expectations in terms of a substantial enough bid for the biosimilars business, with Biogen chief financial officer Mike McDonnell disclosing that "regarding our strategic review of the biosimilars business, at this point we have not received an acceptable offer from a third party."... Global Sub. Full

Glenmark Pharma Receives USFDA Nod for Generic Anti-Inflammatory Drug

(4/29, Press Trust Of India) ...Glenmark Pharmaceuticals on Monday said it has received approval from the US health regulator to sell a generic version of anti-inflammatory drug in the American market...The company's product is the generic version of Haleon US Holdings, LLC's Advil 2 Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), it added. Glenmark Therapeutics Inc, USA will distribute the drug in the US market, the drug maker said... Full

Big Pharma Earnings Watch: Novartis, Merck, Astrazeneca, Bristol Myers Squibb and Sanofi

(4/26, The Campaign for Sustainable Rx Pricing) ...This week, several Big Pharma companies held earnings calls for the first quarter of the year touting revenue and profits beating Wall Street expectations fueled by price hikes and anti-competitive practices, including Novartis, Sanofi, Bristol Myers Squibb, Merck, and AstraZeneca... Full

Elevance Health's CarelonRx Rolling Out New Specialty Pharmacy Savings Tool for Employers

(4/26, Paige Minemyer, Fierce Healthcare) ...Elevance Health's pharmacy benefit manager CarelonRx is launching a new solution that aims to make it easier for employers to plan for the future around specialty pharmacy costs while connecting members with critical support to manage their conditions. The SpecialtyRx Savings Navigator operates across the pharmacy and medical benefits to identify savings opportunities for both the member and employer... Full

Drug Shortages Compounded by Lack of Information, Transparency

(4/26, Erin Clancy, Cancer Therapy Advisor) ...As US drug shortages hit a record high and shortages of cancer drugs impact care across the country, experts say conflicting information and a lack of transparency are making it difficult to manage these shortages. "From my experience, the main issues encountered when managing drug shortages are the inconsistencies and opacities of drug shortage information across reporting sources … and manufacturing sources," said Austin Pytlowany, PharmD, a clinical pharmacist specialist at the University of Michigan Health in Ann Arbor... Full

Weight-Loss Drug Prices Get a Closer Look, Again

(4/29, Tina Reed, Axios) ...With the drugs now available for heart risks and potentially soon for other conditions such as sleep apnea, there's urgent discussion about how to pay for treatments that are hailed as revolutionary but have budget-busting potential. "It's almost hard to imagine what it could mean for total spending on prescription drugs," said Tricia Neuman, senior vice president at health policy research nonprofit KFF...The head of Congress' budget scorekeeper last week said the net costs of the drugs — that is, after any rebates and discounts — would have to drop by 90% to even "get in the ballpark" of not increasing the national deficit, Politico reported... Full

Sanders Presses Pharma Leaders to Change Stance On Pandemic Accord Proposals

(4/26, Lia DeGroot, Endpoints News) ...Sen. Bernie Sanders (I-VT) is calling on global pharmaceutical leaders to get behind proposals laid out in a World Health Organization-led global pandemic preparedness agreement that's nearing completion. On Thursday, Sanders wrote to the International Federation of Pharmaceutical Manufacturers and Associations, a global industry group led by Pfizer CEO Albert Bourla and David Reddy, the group's director general. Sanders, who helms the Senate HELP Committee and has made pressuring drugmakers a cornerstone of his political and policy efforts, urged the group to do more to make sure treatments are accessible... Full

Momentum Builds for House Bill Cracking Down On Chinese Biotechs

(4/26, John Wilkerson, STAT Plus) ...A House committee next month plans to mark up legislation that would restrict U.S. biotechnology companies from doing business with a Chinese company that makes key drug ingredients, according to five lobbyists tracking the BIOSECURE Act. The goal is for the House to pass the bill before the July 4 recess, setting it up to be included in a year-end must-pass legislative package... Sub. Req'd

A Milestone in Facilitating the Development of Safe and Effective Biosimilars

(4/26, Sarah Yim, M.D., Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., The U.S. Food & Drug Administration) ...This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access. Biosimilars are now approved for 15 different reference biologics, and treat illnesses like rheumatoid arthritis, inflammatory bowel disease, some cancers, psoriasis, diabetes, macular degeneration, osteoporosis, and more... Full

CHMP Recommends Eight New Drug Approvals, Six Label Expansions

(4/26, Nicole DeFeudis, Endpoints News) ...It was a positive week for the European Medicines Agency's human medicines committee, which recommended the approval of eight new drugs including Takeda's Fruzaqla and AstraZeneca's Truqap. The committee also voted in favor of six new label expansions. While the European Commission has the final authority over new drug approvals, it typically follows CHMP's recommendations... Full

EU Parliament OKs New Rules On Use Of Patient Data In Research

(4/26, Ian Schofield, Pink Sheet) ...The European Health Data Space is expected to give researchers, industry and public bodies access to large amounts of high-quality health data for the development of new treatments and vaccines. The European Parliament has also approved new rules on Substances of Human Origin... Sub. Req'd

Biocon And Biomm Team Up In Brazil On Ozempic Rival – With Potential Near-Term Launch

(4/26, David Wallace, Generics Bulletin) ...Biocon Limited has set out plans to compete in what it says is a $580m Brazilian market for semaglutide, after striking an exclusive licensing and supply agreement for its Ozempic generic with local player Biomm. Noting that the "vertically integrated" diabetes treatment would be developed, manufactured and supplied by Biocon, the Indian firm said that Biomm would be responsible for obtaining regulatory approval and commercialization in the Brazilian market... Global Sub. Full

Indian Industry Should Focus On Business Risk Mitigation Initiatives to Grab Global Opportunities: DoP Study

(4/29, Pharmabiz.com) ...The Indian pharmaceutical industry needs to focus on various measures including investment in incremental innovation, market and product differentiation, cost reduction and improving efficiency, partnership for technology, market access, and risk sharing, among others to mitigate business risks, according to a study organised by the Department of Pharmaceuticals... Full

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