Friday, November 21, 2025

House Democrats Introduce Bill to Expand Drug Price Negotiation to Commercial Market

(11/20, Paige Minemyer, Fierce Healthcare) ...The bill, titled the Lowering Drug Costs for American Families Act, would allow Medicare to negotiate prices for more drugs each year, from 20 to 50, and make those prices available in the commercial insurance market. It could cap annual out-of-pocket costs for prescriptions and insulin at $35 per month. The legislation also seeks to close a "loophole" established in the One Big Beautiful Bill Act that allows pharmaceutical companies to dodge negotiation for a drug that has orphan status... Full

E&C Dems' Bill Beefs Up Price Negotiations With MFN, More Drugs, Reversal Of Orphan Carve-Out

(11/20, Gabrielle Wanneh, Inside Health Policy) ...The updated Lowering Drug Costs for American Families Act is likely largely a messaging bill to show Democrats want to out-do the drug-pricing deals President Donald Trump has secretively negotiated with individual companies from the Oval Office...One key addition to the revised bill is the provision to directs the HHS secretary to reference international drug prices when negotiating new prices for selected drugs... Sub. Req’d

Biologics To Dominate 2028 Medicare Negotiation Cycle As Eligibility Expands To Part B

(11/20, Cathy Kelly, Pink Sheet) ...Most of the drugs expected to be selected for the next Medicare price negotiation cycle will be biologics, according to a new analysis. Many of the biologics will be immunologics covered under Medicare Part B and Part D. The negotiation targets in the coming cycle have been significantly impacted by the orphan drug exemptions in President Trump's Big Beautiful Bill... Global Sub. Full

Trump's Regressive Deal on GLP-1s Misses the Mark for Patients Like Me

(11/21, Gavin Hart, STAT) ...In summary, under the Trump plan, the U.S. health system continues to fail Americans — by not viewing obesity as a disease, by not prioritizing anti-obesity treatments with all their attendant clinical benefits, and, above all, by not forcing both commercial and federal insurance plans to cover these treatments in a much more inclusive manner... Full

The Trump Administration is Turning Drug Review into Make-a-Deal

(11/21, Daniel Carpenter, Thomas Hwang, and Aaron S. Kesselheim, STAT+) ...With the voucher program, we have now reached a point where science has been replaced by barter and conformity to the vague standard of "national health priorities" is interpreted on the fly. In a medical journal essay published before the Tidmarsh resignation and his remarks about the program, and before the latest round of voucher awards, we warned that the new voucher program could generate corruption, or at least the appearance of it. There are ways to ensure efficient but rigorous drug development without giving out arbitrary and partial favors to companies. Procedural uniformity and transparency are not the enemy of innovation... Sub. Req’d

The Economics Behind U.S. Generic Drug Manufacturing: Part One

(11/19, Off Script) ...In this episode of Off Script, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, about the forces shaping the future of U.S. generic and biosimilar manufacturing... Full

Onshoring Incentives Among US FDA's GDUFA IV Proposals

(11/20, Derrick Gingery, Pink Sheet) ...The FDA wants to add incentives encouraging domestic manufacturing to GDUFA IV, but industry was not sure the idea fit the scope for user fee negotiations. The FDA also proposed changes to combat data integrity issues at manufacturing facilities and CROs. Industry representatives are concerned about recent FDA resource changes and budget constraints... Global Sub. Full

Stakeholders Weigh In on FDA's Draft Clinical Outcome Assessment Template

(11/20, Joanne S. Eglovitch, Regulatory Focus) ...Pharmaceutical industry stakeholders suggested some modifications to the US Food and Drug Administration's (FDA) recently released draft clinical outcome assessments (COA) template for ensuring that treatments are patient-centric and support effective regulatory decision-making... Full

AbbVie, Novartis Can Proceed with Legal Fight Against Utah 340B Law

(11/20, Alexis Kramer, Endpoints News) ...AbbVie and Novartis can continue challenging a Utah law that regulates how drugmakers distribute 340B discounts, a federal court held. The ruling is another small win for the pharma industry as it fights across circuits to knock down state 340B laws. States have prevailed in a majority of cases so far, but Wednesday's decision marks AbbVie's second victory this month... Sub. Req’d

FDA Approves Denosumab Biosimilars, Osvyrti and Jubereq, for Reference Products' Indications

(11/20, Gillian McGovern, Pharmacy Times) ...Osvyrti and Jubereq are denosumab biosimilars approved for osteoporosis and cancer-related bone conditions, mirroring Prolia and Xgeva indications. Clinical trials demonstrated comparable pharmacokinetics, pharmacodynamics, safety, and efficacy between the biosimilars and their reference products. The approval of these biosimilars aims to reduce treatment costs and improve accessibility, with Accord BioPharma leading their independent development and manufacturing. This approval is part of a growing trend of denosumab biosimilars entering the market, enhancing treatment options and cost savings in the healthcare system... Full

Alvotech Positioned As Sole Simponi Biosimilar For ‘Months' With EU Approval

(11/21, Dean Rudge, Generics Bulletin) ...Approval of Gobivaz across the 30-country EEA introduces long-awaited competition to Simponi, though the partners have yet to confirm a commercial launch date...An Alvotech spokesperson did not respond to Generics Bulletin's request for comment. On the Icelandic's recent third-quarter earnings call, management did, however, indicate that the firm "intends to proceed with the launch promptly after approval, and anticipate being the sole biosimilar to Simponi available on the European market for several months."... Global Sub. Full

Formycon Must Be ‘Self-Critical' As Biosimilar Competition Intensifies

(11/21, Dean Rudge, Generics Bulletin) ...Facing intensified biosimilar competition, Formycon has stressed the need for more optimal development timelines and tighter cost controls. The German firm is looking to leverage automatization, digitalization and AI technologies going forward to help to smooth its procedures. Having just revealed a biosimilar to Dupixent is in its pipeline, Formycon says potential partners are monitoring the situation... Global Sub. Full

Biocon Eyes Acceleration Phase As USFDA Draft Guidelines Open Door To Cheaper Biosimilars: Kiran Mazumdar-Shaw

(11/21, Divya Prata, NDTV Profit) ...Biocon is stepping into a decisive new phase in its evolution as a global biosimilars powerhouse, propelled by regulatory shifts in the US, fresh strategic partnerships, and a strengthened insulin and GLP-1 pipeline, executive chairperson Kiran Mazumdar-Shaw told The Economic Times..."We are in a sweet spot and a very unique position," Mazumdar-Shaw said in her conversation with ET. She pointed out that Biocon is the only player with interchangeable insulins at a time when traditional insulin manufacturers are shifting their focus toward GLP-1s. "We are taking that advantage globally," she said... Full

Amphastar Expects Mysterious Inhaler Candidate To Be The ‘Most Meaningful' Revenue Driver In 2026

(11/21, Urte Fultinaviciute, Generics Bulletin) ...Amphastar Pharmaceuticals hopes to launch its undisclosed generic inhaler mid-2026. While the product is yet to be approved by the US FDA, the firm believes it will be "the most meaningful" growth driver. Another unapproved product, AMP-015, which references Eli Lilly's Forteo (teriparatide), is also expected to launch next year. The firm continues to build on its biosimilar pipeline, with an insulin aspart rival to be commercialized in 2027... Global Sub. Full

Obesity Drug Access Grows as Novo, Lilly Sell Direct to Employers

(11/21, John Tozzi and Madison Muller, Bloomberg) ...Lilly and Novo are already selling the drugs to patients through online "direct" services at big discounts to their list prices. While details are still scarce about how much workers will have to pay under the new model, with each employer determining how much the out-of-pocket payment will be for patients, a number of companies have already expressed interest, Waltz Chief Executive Officer Mark Thierer said in an interview. Thierer declined to share what prices the company has negotiated with the drugmakers, but he said they were competitive. "This will be the absolute cheapest way" for a person on an employer benefit plan to get the drugs, he said... Sub. Req’d

Contineum's J&J-Partnered MS Drug Fails to Improve Vision in Phase 2

(11/20, Gabrielle Masson, Fierce Biotech) ...The Johnson & Johnson-partnered asset, coded PIPE-307, failed to trigger a significant change in binocular 2.5% low contrast letter acuity across treatment arms, the San Diego biotech reported after market close Nov. 20. The lack of significant change caused the trial to miss its primary efficacy goal, and the study failed to hit secondary efficacy endpoints as well... Full

Merck KGaA to Draw on Valo's Drug Discovery AI in Potential $3 Billion Deal

(11/20, Ludwig Burger, Reuters) ...Germany's Merck KGaA on Thursday agreed to use Boston-based Valo Health's drug research services in a collaboration focused on Parkinson's and related diseases that is potentially worth over $3 billion to the U.S. company. The pact, which is focused on finding promising therapeutic molecules, underscores Merck's ambition to revive growth at its pharmaceutical division after the $3.9 billion takeover of rare cancer specialist SpringWorks... Full

Texas Sues Bristol Myers, Sanofi for Concealing Blood Thinner Plavix's Alleged Ineffectiveness

(11/20, Jonathan Stempel, Reuters) ...Texas Attorney General Ken Paxton sued Bristol Myers Squibb and Sanofi on Thursday, accusing the drugmakers of failing to disclose that Plavix, which is used to prevent blood clots, does not work effectively for many patients. In a complaint filed in a state court in Harrison County, Texas, Paxton said the drugmakers knew or should have known since 1998 that Plavix had "diminished effect" on Black, Asian and Pacific Islander patients, but no warning was added to the blood thinner's label until 2010... Full

Health Canada's Agile Licensing and Real-World Evidence

(11/20, The Pharma Letter) ...Health Canada is reshaping how medicines move through the regulatory system, pitching its agile licensing framework as a way to keep pace with evidence as it emerges, rather than as it concludes. The ambition is straightforward: approvals should reflect reality, and real-world evidence should help refine a drug's story after launch. The harder question is where this actually happens, and whether real-world evidence (RWE) genuinely influences label change or conditional approvals, rather than simply appearing as a footnote to traditional trials... Sub. Req’d

Health Canada Approval Backlog Expected to Push Back Arrival of Generic Ozempic

(11/20, Chris Hannay, The Globe and Mail) ...Health Canada cannot give a full approval for a generic drug until market exclusivity ends – which for semaglutide is Jan. 4 – but generic drugmakers say progress so far is casting doubt on the notion that approvals will be ready then. Sandoz Canada Inc., a subsidiary of generics giant Sandoz Group AG, filed its application in November, 2024. A year later, the company is still answering questions from Health Canada about its submission. Michel Robidoux, general manager of Sandoz Canada, said more Canadians will be able to access the drug and they will save money when the cheaper, generic version is available. "So we are working very hard, but the road to get this drug approved is probably longer than expected."... Full

India's Pharma Exports Nearing $30 Billion

(11/21, BW Healthcare World) ...As India aspires to become a $30 trillion to $35 trillion economy by 2047, the pharmaceutical industry is poised to play a critical role in driving economic growth and enhancing public health, as per a latest report by EY Parthenon and Organisation of Pharmaceutical Producers of India (OPPI). There are three interlinked pillars defining India's pharmaceutical industry: dominance in generics and vaccines, the advancing CRDMO/CDMO sector, and the expansion of Global Capability Centers... Full

Union Minister Nadda Urges Pharma Industry to Decrease Import Reliance on APIs and Boost Innovation

(11/21, Press Trust Of India) ...In a video message at 60th Annual Summit of the Organisation of Pharmaceutical Producers of India (OPPI), he urged industry leaders to accelerate innovation in biosimilars, novel molecules, gene and cell therapies, AI-driven drug discovery, and advanced diagnostics while ensuring equity and affordability remain central pillars of India's health vision... Full

Eight African Agencies Finalizing Reliance Mechanism To Speed Drug Approvals

(11/20, Neena Brizmohun, Pink Sheet) ...The regulatory agencies from Senegal, Egypt, Ghana, Zimbabwe, Nigeria, Rwanda, South Africa and Tanzania are finalizing procedures for a new reliance mechanism to accelerate access to medicines across Africa, support local pharmaceutical manufacturing and boost intra-African trade. The new mechanism will allow the agencies to share information and rely on each other's assessment reports so that they can reduce duplication of work and ensure timely regulatory decision-making. The reliance pathway strengthens the goals of key continental health initiatives including the African Medicines Agency, which started becoming operational earlier this year... Global Sub. Full

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