Biosimilars & Generics

Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.

Discussions are ongoing at Health Canada on the feasibility of adopting the UK model of easing clinical study requirements for biosimilars, said director general Celia Lourenco at a recent event. Meanwhile, the US FDA’s stance is unchanged for now.

Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.

US FDA chief scientist said former exec, who was part of the generic drug scandal, deserves special termination of 1993 debarment due to his 'substantial assistance' to the DOJ in its investigations of others. Office of Regulatory Affairs wanted to deny his petition.

Concerns that Medicare drug price negotiation provisions in the Build Back Better legislation would upend the generic and biosimilar industries might resonate with legislators more than complaints from branded drug companies.

Biosimilars continue their erratic behavior, with the low numbers driving big swings.

Belgian off-patent industry association Medaxes has welcomed a court decision to reject a brand industry challenge over the exemption of generics from the country’s pharmaceutical clawback tax.

New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.

Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.

Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.

The European Commission’s proposals for solving the post-Brexit regulatory problems relating to the Northern Ireland market are welcome but they do not go far enough and risk leaving suppliers in a legal limbo, says the off-patent medicines industry.

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.