The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.
The European Medicines Agency has accepted for review Organon’s application for its Henlius-partnered Perjeta (pertuzumab) biosimilar, paving the way for approval in a major global market.
The Perjeta biosimilar was the subject of a $100m+ deal between Organon and the Chinese company Shanghai Henlius Biotech signed...
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Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
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 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.
At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.
Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.
Joshi joins the parent company of Citeline, which houses flagship publications Generics Bulletin, Scrip and Pink Sheet, to focus on AI, business harmonization and long-term growth.
