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Monitoring To Start As SPC Waiver Nears Finishing Line

 
• By Aidan Fry

A manufacturing waiver to allow EU-based companies to produce generics and biosimilars during the SPC term should be approved imminently. But the European Commission is watching closely to see if the provision is used by industry.

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The SPC Waiver Regulation Is Nearing The Finish Line • Source: Shutterstock

The European Commission is preparing to start monitoring the impact of the planned manufacturing waiver that will allow generics and biosimilars developers to produce products within the term of European supplementary protection certificates (SPCs). Alfonso Calles-Sánchez, administrator within the Commission’s directorate general Grow, told delegates to Medicines for Europe’s 15th Legal Affairs Conference that he anticipated a vote in the plenary of the European Parliament in mid-April as one of the final steps to the waiver being approved.

Noting that the inter-institutional agreement between the European Council, Parliament and Commission unveiled in mid-February this year had permitted stockpiling...

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More from Regulation

Alchem Fined Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
• By Dean Rudge

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

 
• By Dean Rudge

The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

More from Policy & Regulation

FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Finds No ‘Serious Discrepancies’

 
• By Dean Rudge

The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

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.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

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.