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Ringside For Zarxio At Supreme Court: Biosimilar Stakeholders Line Up

 
• By Brenda Sandburg

High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.

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The shape of biosimilar litigation for years to come will be on the line April 26 when the Supreme Court hears oral arguments in the Sandoz Inc. v. Amgen Inc. case. Depending on the decision, biosimilar sponsors could face protracted litigation and even launch delays, and with so much on the line, innovator companies, biosimilar applicants and other stakeholders filed a slew of amicus briefs.

The court is to consider two questions about the requirements of the Biologics Price Competition and Innovation Act (BPCIA): Must a biosimilar sponsor wait until after FDA approval to provide 180-day notice of commercial marketing of its product

Biosimilar sponsors say having to wait until approval to tell innovators they plan to market their products gives the innovator an extra six months of marketing exclusivity and delays resolution of patent disputes

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.