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Biosimilars & Generics

Set Alert for Biosimilars & Generics

AAM CEO Leonard Departs After Two Years, Creating Another Trade Group Searching For New Leader

David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person to run the association since February 2020.

Generic Drugs Leadership

US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden

Sen. Mike Lee, R-UT, has introduced draft legislation in the US that would stop the FDA from requiring biosimilars to conduct ‘unnecessary’ switching studies in order to obtain an interchangeability designation.

Legislation Regulation

Brazilian Regulator Consults On Improving Rules For Registering Biosimilars

ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.

South America Brazil

Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims

Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.

Intellectual Property Generic Drugs

Amgen Mvasi, Kanjinti Sales Decline As Biosimilars Industry Faces New Policy Challenges

ASP metric used in Medicare, and often in commercial insurance, for reimbursement of physician-administered drugs is an important factor in the sales arc for biosimilars. Price negotiations under IRA could bring their own margin-squeezing pain to pharmacy-benefit biosimilars.

Biosimilars Reimbursement

Generic Sample Access Process For REMS-Protected Brands Now Includes Agency Timeline

US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.

Generic Drugs Research & Development

Sanofi & GSK Win COVID-19 Vaccine Approval In EU Using Immunobridging Trials

The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.

Europe Approvals

Negotiators Prioritize Generic And Biosimilar Oncology Medicines Over Newer Drugs

The Union for International Cancer Control and the World Health Organization are prioritizing off-patent drugs in their efforts to facilitate oncology medicine access in developing nations.

Biosimilars Generic Drugs

What Will USPTO-FDA Collaboration Look Like? Stakeholders To Weigh In On Proposed Initiatives

Agencies are holding public ‘listening session’ to get input on method of use patents and ‘skinny labeling,’ REMS patenting, PTAB proceedings and other topics.

Market Access Pricing Debate

US FDA’s New Acting Generics Chief Relearning System After 24 Years Of Experience

Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.

Generic Drugs Leadership

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

MSD Fined €39m In Spain Over Blocking Nuvaring Rival

Spanish competition regulator the CNMC has fined Merck Sharp and Dohme €39m for abusing its dominant position, by blocking Insud Pharma’s rival to the Nuvaring vaginal contraceptive ring through “unjustified legal action” that sought to delay market entry of Insud’s Ornibel version. The originator is considering an appeal.

Legal Issues Intellectual Property
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