Biosimilars

BC Partners has completed its acquisition from Servier of French generics giant Biogaran after the French government allowed the private-equity takeover on condition that BPI France take a minority stake. Meanwhile, former Biogaran CEO Erick Roche has returned to the role after a long stint at Teva.

Just a few days after Alvotech announced global settlements for its Eylea rival, Samsung Bioepis has followed up with its own agreements with the originators.

Sandoz and Alvotech have struck a deal that will see the firms collaborate on multiple biosimilar candidates for the Australian, Canadian and New Zealand markets across therapeutic areas including ophthalmology, immunology and gastroenterology.

The US Association for Accessible Medicines has named Lupin’s Bob Hoffman as its new chair. Meanwhile, departures have been seen at Stada and Dr Reddy’s, among other industry management changes.

Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.

Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.

Teva says it has 10 additional biosimilars in development for launch from 2028 onwards, extending its portfolio beyond 2027 as it targets European growth and expands through partnerships.

Even though the ink has long dried on the US-South Korea trade deal, new threats have prompted Celltrion to reiterate its “fundamental solution” to tariff concerns.

With the separation from its parent company now behind it, Samsung Bioepis celebrated its highest-ever annual revenues and outlined its vision of further growth.

MS Pharma is continuing to capitalize on opportunities for localized manufacturing in the Middle East, with its latest deal with Hetero Biopharma covering five biosimilars.

Responding to recent FDA guidance on a new streamlined pathway for US biosimilars, off-patent industry representatives have urged the agency to make the approach “the new default” for biosimilar filings. However, PhRMA has suggested limiting the route to less complex product types.

As Dr Reddy’s delivered results for its financial third quarter, the firm revealed a slew of updates for key biosimilars in its pipeline including filing and launch plans for abatacept in the US and Europe, as well as US setbacks on rituximab and denosumab.

BMS will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company.

Generics Bulletin reviews global regulatory developments across the world.

Hikma has launched its Enoby and Xtrenbo denosumab biosimilars to Amgen’s Prolia and Xgeva into the competitive US market. How will the firm fare against so many other rivals?

Biocon Biologics has become one of the most prominent global biosimilars firms since its buyout of former partner Viatris’ biosimilars business. With a rumored IPO instead making way for a merger with generics unit Biocon Ltd, the business’s chief Shreehas Tambe sets out the reasons for the move.

Sun terms reports of acquisitive interest in Organon as "speculative," at least for now. Bankers see a potential transaction fit the profile of a 'typical’ Sun deal, which if it occurs also catapults the Indian firm’s foray into biosimilars.

With needed funds in its pocket, Biocon is prepared to simplify and integrate its growing off-patent medicines portfolio under one roof.

Samsung Bioepis has significantly expanded its biosimilars pipeline with the addition of six new candidates. Management provided full details at the J.P. Morgan Healthcare conference.

Amneal sees vertical integration of its biosimilars business, as well as global partnerships, as a key advantage to remain at the top of the game ahead of upcoming competition.