Biosimilars & Generics

The FDA’s experience with product-specific guidances for generic drugs may impact biosimilar industry decision-making, but the program has improved in recent years.

The Alliance for Safe Biologic Medicines urged restraint when considering FDA findings suggesting switching studies may not be as vital to support interchangeability.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies and secure the supply of generics and biosimilars.

Lytenava, Outlook Therapeutics’ ophthalmic version of bevacizumab for wet AMD, has been given the INN bevacizumab gamma, but it is not a new active substance, the EU authorities have confirmed.

In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.

The House Appropriations Committee indicates in fiscal year 2025 appropriations report language that lawmakers will closely monitor the FDA’s implementation of clinical trial diversity action plans. 

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.

In long-running litigation over perindopril ‘pay for delay’ settlements, appeals have been refused and certain earlier findings by Europe’s general court have been set aside in a fresh ruling by the Court of Justice of the EU.

Divisional patents remain a major barrier to market entry for generics in Europe, heard attendees to Medicines for Europe’s legal affairs conference in Dublin earlier this month.

The FDA followed the EMA’s lead and declared Synapse’s trials “unacceptable” forcing drug firms that used CRO’s services to repeat studies to regain therapeutic equivalence ratings.

While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Did Samsung Bioepis and Biogen choose early US access for their Lucentis biosimilar in exchange for postponing launch in other markets? That’s what Italy’s competition authority believes, as it investigates the biosimilar sponsors and originator companies Genentech and Novartis.

In an ‘ask me anything’ Q&A on Reddit, Sarah Yim, director of US FDA’s Office of Therapeutic Biologics and Biosimilars, offered some insights on the US biologics naming convention, biosimilar interchangeability, and the possibility of future competition on cell and gene therapies.

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.