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Biosimilars & Generics

Set Alert for Biosimilars & Generics

Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Biosimilars Reimbursement

Drug Pricing Reform As Legislative ‘Pay For’ Gaining Momentum But What About Part D Redesign?

Association for Accessible Medicines makes a case for lowering prices in Part D through benefit design reforms enabling quicker and better access to first generics.

Pricing Debate Medicare

Pink Sheet Podcast: As Aduhelm Turns, Teva Sues Under CREATES Act, Neulasta Untitled Letter

Pink Sheet reporters and editors discuss another explanation of the FDA’s Aduhelm label, the first lawsuit attempting to force the sale of samples for generic development, and the agency questioning promotion of Amgen’s Neulasta.

Neurology Legal Issues

Firms Vow To Appeal After CMA’s £260m Hydrocortisone Fines In UK

Firms censured by the UK’s CMA competition regulator over illegal deals that drove up the price of hydrocortisone for around a decade have vowed to appeal against the decision and the imposition of fines totaling more than £260m.

United Kingdom Legal Issues

Teva, In First-Ever CREATES Act Suit, Seeks Help With Fabry Disease Generic Development

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Generic Drugs Legal Issues

Amgen’s Neulasta Ad Indirectly Targeting Biosimilars Draws US FDA Rebuke

Animated banner ad claiming administration of Neulasta with Amgen’s Onpro on-body injector has less risk of febrile neutropenia than administration via prefilled syringe draws untitled letter and a rare press release. FDA says claims could undermine confidence in biosimilar pegfilgrastim products.

Ad Complaints Advertising, Marketing & Sales

Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement

Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

Biosimilars User Fees

Global Generics & Biosimilars Industry Sets Out Vision To 2030

Headwinds as well as opportunities for the off-patent industry are discussed in a comprehensive new whitepaper by the International Generic and Biosimilar Medicines Association

International Biosimilars

Importation, Pay-For-Delay Reform Backed By Biden Order; March-In Rights For Pricing Suggested

The policies have long been Democratic priorities, but of the three, the order’s implicit support for march-in rights might lead to the biggest change.

Pricing Debate Intellectual Property

Environmental Criteria in Medicines Tendering Set To Increase

Environmental criteria in tendering could lead to short term cost increases but long-term savings for pharmaceutical companies.

Europe Denmark

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe Approvals

Some Generics May Get To Skip Fed Study Requirement If US FDA Research Pans Out

Office of Generic Drugs official says the FDA may be able to harmonize its requirements with regulators who do not have a blanket mandate.

Generic Drugs Research and Development Strategies
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