Regulation

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.

As Biocon Biologics picks up the latest approvals in Europe for its Stelara biosimilar, Blake Leitch, the firm’s head of Europe, talks to Generics Bulletin about what lies ahead for Biocon and for biosimilars more widely in the region – including tackling the “biosimilar void”.

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

The agency says items on its Human Foods Program’s proposed agenda for guidance “to complete during 2025” include identity and safety information for NDI notifications. Its announcement also links to document about a separate key industry question, a rulemaking which would recognize NAC as a lawful

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

FTC decision, says Bureau of Competition director Daniel Guarnera, influenced by both companies marketing different lines in different countries, limiting the number of similar products in the same categories the combined firm would offer.

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Dietary Supplement Caucus e-launched the 119th Congress with Utah Republican House member Mike Kennedy and Texas Democrat member Marc Veasey as co-chairs and with a total of nine senators and 20 House members spanning both parties.

Modifications to forms FDA 3500, for voluntary reporting by healthcare professionals, and 3500A, for mandatory reporting by manufacturers, marketers or facilities, include limiting changing gender question to sex and asking for only male or female answer.

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.