The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

Finalists across all 14 categories of the Global Generics & Biosimilars Awards 2021 have been revealed ahead of the awards ceremony on 10 November, following record entries this year.

BioFactura, which is already using its ‘StableFast’ technology platform to develop its biosimilar ustekinumab candidate, has allied with fellow US-based biotech Rani Therapeutics to see if the biologic can be formulated into Rani’s proprietary ‘robotic’ pill.

Intas and Arecor have struck an exclusive licensing deal that will see the pair use Arecor’s proprietary Arestat formulation technology to develop value-added medicines, in particular for use outside of the hospital setting.

CNS specialist Neuraxpharm has announced expanding its strategic collaboration with Panaxia Labs Israel for advanced medical cannabis-based pharmaceutical products to Poland, after Germany and France. The companies expect sale of the cannabis portfolio to commence in the first half of 2022.

In an exclusive interview with Generics Bulletin, the CEO of API and FDF manufacturer Xellia Pharmaceuticals, expresses concern over supply chain resilience of the US and the EU, as he points out the weaknesses exposed by the pandemic. The company has also announced the release of its first anti-infectives manufactured at its newly operational Cleveland site. 

India’s Dr Reddy’s has sold the US and Canadian rights to its 25mg/ml Elyxyb (celecoxib) oral solution to US-based BioDelivery Sciences International, for an upfront payment of $6m, followed by $9m within one year from closing the deal.

This article brings you a compilation of all the data from Generics Bulletin’s recent ranking of the top 50 generics and biosimilars companies, including additional details of how the financial figures stack up.

Biosimilars players are gaining an increasing foothold in the off-patent industry, as demonstrated by the final part of our annual Top 50 ranking.