Business

Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.

Six companies exceeded $20bn in the latest Top 100 ranking of global medtechs by revenues, but with a slew of structural changes ahead, the leader board could change in 2026.

Prestige Biopharma has picked Biosidus to manufacture and export its Tuznue biosimilar rival to Herceptin across four Latin American countries.

Amphastar sees two highly likely launches in 2026, with one of them significantly contributing to next year's revenues. However, both generics are yet to be approved by the US FDA.

Favorable regulatory winds in the US are leading Lupin down the biosimilar path, as it also hopes that the potential US generic-first policy will boost its wider off-patent drug portfolio. However, it is also facing several facility compliance setbacks.

Amneal continues to see biosimilars as an attractive but competitive space, with vertical integration in the US market being a key to its success.

The biosimilar partnership between Samsung Bioepis and Biogen continues to crumble, with commercialization rights to Lucentis and Eylea biosimilars shifting hands now in Europe.

Formycon and its aflibercept biosimilar partner Klinge shook hands with Actor Pharmaceuticals and Megalabs to market the Eylea rival in their respective regions.

Bio-Thera and Accord build on their North American golimumab biosimilar partnership, with Canada being a valuable market for both firms.

With a “sharpened focus,” Polpharma Biologics has spun out its contract development and manufacturing business into a separate company.

Takeda's APAC chief talks about driving affordability and access for products like Adcetris and Qdenga, focusing on the region's diverse needs. “Watch this space” he said on the Japanese group’s Innovation Capability Centers, as they shape digital solutions to transform operations.

Learn more about the challenges faced by today’s drug developers and the critical factors to consider as sponsors navigate the supply chain, keep up with regulatory requirements, and ensure patient access. Discover more about the role of generics and how Aspire Pharma can help.