Generics Bulletin
Lupin has agreed a “long-term strategic alliance” with CDMO PolyPeptide that the firm says will bolster its supply chain for peptide APIs.
The UK generics market risks becoming unsustainable as prices hit “rock bottom,” the House of Lords has been warned in a letter signed by multiple stakeholder associations including Medicines UK.
In a busy year for US biosimilars, more than a dozen approvals were seen as multiple brands faced competition for the first time – including Stelara. However, concerns persist over the “biosimilar void”, with hope that the latest FDA announcement on regulatory streamlining can help to fill the gap.
Alvotech and Teva have become the latest Eylea biosimilar developers to announce a settlement allowing a US launch in late 2026. However, first they must clear the hurdle of FDA approval following a recent CRL.
Glancing over at the changing development requirements for biosimilars in the US and Europe, the Chinese duo Chime Biologics and Beijing Libang Pharmaceutical are allying to develop a blinatumomab biosimilar rival to Amgen’s Blincyto.
Generics Bulletin reviews global regulatory developments across the world.
Licensing agreement expands Polpharma’s footprint in Latin America while supporting Libbs’ strategy to grow access to advanced biologics in Brazil.
Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.
The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.
UK liquids specialist Rosemont Pharmaceuticals has named industry veteran Alok Sonig as its new CEO, as the firm continues to set its sights on the US market. Meanwhile, Rosemont has also appointed Gavin Wood as chief financial officer.
Decision matches earlier Dr Reddy’s outcome, although no injunctive action involved, allowing exports to non-patent markets ahead of a post-expiry launch.
Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.
After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.
The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.
Sandoz said it was “asserting biosimilars leadership” as it announced the completion of a deal to acquire Just-Evotec Biologics’s Toulouse development and manufacturing site as well as an indefinite licence to the firm’s continuous manufacturing technology.
Hikma has initiated a leadership transition, with CEO Riad Mishlawi stepping down after just two years in the role, as margin pressure in its core Injectables business and operational delays weigh on performance.
After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.