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Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.
Viatris and Biocon have introduced their Abevmy biosimilar bevacizumab version of Avastin in Canada. Marking the third oncology biosimilar – and the fourth biosimilar overall – to be launched by Viatris in Canada, the product will face multiple other approved bevacizumab rivals in the market.
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.
Craig Burton is stepping up to become executive director of the US Association for Accessible Medicines’ Biosimilars Council, as Christine Simmon has moved on to become president and CEO of the Food and Drug Law Institute. At the same time, Burton has added oversight of strategic alliances to his existing policy role with the AAM.
In the wake of parent company Samsung Biologics completing its full acquisition of Samsung Bioepis, the Korea-based biosimilars player has told Generics Bulletin that it will be a “more robust company,” as it applies more rigorous standards to replenishing its pipeline of biosimilar candidates.
Alvotech has reported positive results from a study for its AVT04 proposed biosimilar ustekinumab rival to Stelara. The news comes ahead of a key vote on Alvotech’s SPAC merger with Oaktree Capital Management that will take the company public.
Enbrel (etanercept) originator Pfizer has filed suit in Australia over the sale of Samsung Bioepis’ rival Brenzys biosimilar. It alleges that it has “suffered, and will continue to suffer, substantial loss and damage.”
Generics Bulletin sits down with Biosimilars Forum executive director Julie Reed to discuss preparing the HHS for Humira biosimilars, what more the agency could do for the industry and the Forum’s priorities over the next year.
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