Coherus BioSciences has sold a little under 2.5 million shares to partner Junshi Biosciences, giving the firm additional capital following a large debt financing last year.

Lotus Pharmaceuticals aims to build a stronghold in Thailand and beyond, after the Alvogen subsidiary announced a partnership with a subsidiary of Thai state-owned conglomerate PTT, which includes a $50m capital injection.

Canada’s PlantForm has struck a deal with Brazil’s Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab rival to Merck’s Keytruda for the Brazilian market and potentially beyond.

Aurobindo has announced the launch of generic versions of Truvada, Atripla, Minocin and Gleevec in the US. As its generics business grows in the US, Europe, Canada and the rest of the world markets, Aurobindo plans to establish itself in China. The Indian pharma company has also announced its plan to commission new facilities to serve the external market. 

As Michael Sen takes the reins as CEO of Fresenius Kabi, Christian Pawlu has been recruited from Sandoz to head up the firm’s generics and complex formulations unit.

Russia’s Pharmapark has added Prestige BioPharma’s HD204 biosimilar bevacizumab product to the firms’ commercialization partnership, two years after kicking off the partnership with trastuzumab.

Action is needed from both the UK government and the European Commission to prevent a collapse of Northern Ireland’s generics market, according to the BGMA.

The FTC has won the backing of an appeals court over its 2019 decision that found a reverse-payment settlement deal between Impax and Endo over Opana ER to be anti-competitive and illegal.

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.

Biosimilars industry stakeholders have suggested ways to enhance communication and improve the US regulatory pathway for biosimilars, as they weighed in on an interim assessment of the program for enhanced review transparency and communication in the Biosimilar User Fee Act II, ahead of the upcoming reauthorization of BsUFA for fiscal years 2023 through 2027 by the FDA. 

Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.

The Advancing Education on Biosimilars Act and the Ensuring Innovation Act will be looked at by the US President Joe Biden, after receiving the approval of both the Senate and the House of Representatives. The bills are aimed at lowering prescription drug costs and saving overall healthcare costs. 

Aurobindo has announced the launch of generic versions of Truvada, Atripla, Minocin and Gleevec in the US. As its generics business grows in the US, Europe, Canada and the rest of the world markets, Aurobindo plans to establish itself in China. The Indian pharma company has also announced its plan to commission new facilities to serve the external market. 

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

The Advancing Education on Biosimilars Act and the Ensuring Innovation Act will be looked at by the US President Joe Biden, after receiving the approval of both the Senate and the House of Representatives. The bills are aimed at lowering prescription drug costs and saving overall healthcare costs. 

Amgen has hit back at Sandoz’ petition for a writ of certiorari against a US Court of Appeals for the Federal Circuit decision that leaves the biosimilar sponsor unable to market its Enbrel biosimilar more than three decades after the biologic was first launched.

Canada’s PlantForm has struck a deal with Brazil’s Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab rival to Merck’s Keytruda for the Brazilian market and potentially beyond.

Glenmark has struck the latest in a series of commercialization deals for its Ryaltris nasal spray in the form of a ten-year alliance with Bausch Health for the Canadian market.

After partnering with companies like Purna Female Healthcare and AFT Pharmaceuticals, Belgian value-added medicines specialist Hyloris has announced plans to add three new products to its pipeline in the coming months with a goal of having 14 commercial products by 2024. 

Licensing new uses of existing medicines has several benefits over off-label use, such as offering assurances that the indication is evidence based and subject to an ongoing safety monitoring program, according to a new report.