Biosimilars & Generics

While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection-related delays for multiple products – there were nevertheless several firsts this year, including the first two interchangeables and the first ophthalmic biosimilar.

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

Further analysis is under way, but first impressions by EU R&D industry group EFPIA of policy proposals for tackling drug shortages are not good.

Optional checklists will help ensure submissions have all the required information.

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.

While the FTC referral is not unique, this seems the first time US FDA has cited intent to delay generic approval as a ground for denying a citizen petition. With Califf's confirmation hearing suggesting some bipartisan consensus on the issue, FDA might soon find itself with new powers.

Other companies have largely halted practices at issue in the ‘diabolical anticompetitive plan’ undertaken by Shkreli’s former firm. FTC did not challenge the price hike for Daraprim itself, but did cite an effort to block release of sales data and other tactics to discourage generics.

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

Medicines for Europe has urged the European Commission to enshrine security of supply considerations for essential medicines into legislation. Without these, it says, additional cost containment measures for off-patent medicines under consideration by member states could threaten access by making production unsustainable for manufacturers.

US FDA largely writes biosimilar labels that are the same as their reference products even though it’s not required, which could hinder product development and uptake, experts say.

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.