Biosimilars & Generics

A report beefing up the proposals contained in the European Commission’s Pharmaceutical Strategy has been approved by an influential parliamentary committee that wants to see a “stable, updated and safety-centered regulatory system” and an "autonomous and resilient" pharmaceutical industry.

The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.

The World Health Organization’s updated essential medicines list includes four medicines already licensed to the Medicines Patent Pool, of which two were developed through MPP licensees. The WHO’s updated list includes SGLT2 inhibitors – oral medications used to lower blood glucose levels – for which the MPP and the International Diabetes Federation have committed to improve affordable access in low- and middle-income countries.

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Bills to reign in petitions, pay-for-delay, product hopping, and patent thickets clear House Judiciary Committee. Legislation may have better shot at enactment this time around given bipartisan support in both House and Senate Committees.

The incentives system, access to medicines, future proofing for novel products and antimicrobial resistance are just some of the topics included in a new consultation.

US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.

Six supplement categories based on submission content will be created with review goals between three and 10 months.

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

US FDA's updated Q&A guidance on developing generics for submission via the abbreviated new drug application pathway during the COVID-19 pandemic has been published.