In a year that has seen significant changes throughout the generics and biosimilars industry ranking, the top 10 has welcomed two Indian off-patent leaders. Meanwhile, companies lower down our ranking have enjoyed mixed fortunes, leading to a number of significant movements in this year’s Generics Bulletin Top 50.

A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.

Upcoming opportunities facilitated by the EU’s pharma legislation review were highlighted at Medicines for Europe’s fifth annual value added medicines conference, held in Brussels this month. However, enthusiasm was tempered with acknowledgements that the European sector current lags behind the US and needs further reform to attract investment.

As Samsung Bioepis seeks a US interchangeability designation for its Organon-partnered Hadlima adalimumab biosimilar, the firm’s regulatory affairs chief Byoungin Jung talks to Generics Bulletin about the significance of interchangeability for US biosimilars – and the firm’s support for legislative efforts to have all US approved biosimilars automatically designated as interchangeable.

A fresh batch of product-specific guidances to aid generics development has been published by the US Food and Drug Administration, including new documents covering Wegovy, Duobrii and Radicava ORS, as well as revised PSGs for Celestone Soluspan and Gralise.

A fresh UK voluntary pricing scheme for branded medicines has been unveiled that includes differentiated payment mechanisms for older and newer products. However, the BGMA has hit out against aspects of the new deal that it says will provide hurdles for generics and increase the risk of drug shortages.