Biosimilars & Generics

A new committee including representatives of the French pharma industry, health professionals and patients is to lay the groundwork for a longer-term approach to preventing and managing medicine supply chain issues. A separate initiative launched by the prime minister will look at medicines access issues and strengthening the French manufacturing base.

Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.

Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.

Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.

First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.

PTO judge says she is ‘intrigued’ by request for patients to be involved in patent discussions and examiner training. Patients advocated for a seat at the table during USPTO-FDA’s ‘listening session’ on initiatives to promote greater access to medicines.

Pink Sheet reporters and editors discuss the take-aways from Leqembi’s approval as an Alzheimer’s treatment, the new timeline for information collection and comment on Medicare price negotiations, and the reasons a generic drugs trade association CEO departed.

In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.

The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.