Stada resubmits biosimilar pegfilgrastim but stops adalimumab development

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German generics giant Stada Arzneimittel (Stada) was informed on 2 March 2018 by Gedeon Richter (Richter) that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed pegfilgrastim biosimilar. However, in another press release the company announced that it was stopping development of its adalimumab biosimilar.

Meeting V13F14

Stada’s product is a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim), which had worldwide sales of US$4.7 billion in 2016. Stada and Hungary-based Richter signed licence and collaboration agreements for the development and marketing of two biosimilars back in August 2011 [1].

The EMA submission for the pair’s pegfilgrastim biosimilar was withdrawn in December 2016 after EMA’s Committee for Medicinal Products for Human Use (CHMP) indicated that the data provided did not allow the committee to conclude a positive benefit-risk assessment. 

The resubmission follows the successful completion of an additional clinical study, which provided data demonstrating biosimilarity of both the pharmacokinetics and pharmacodynamics of the proposed biosimilar and Neulasta. The pegfilgrastim biosimilar is currently under review by EMA for the same indications as the reference product.

However, in a statement by Stada’s CEO Claudio Albrecht on 8 March 2018, the decision to stop development of the company’s adalimumab biosimilar was announced. The decision comes as part of a move to modernize Stada and to focus its speciality pharmaceuticals, which include biosimilars, on oncology, CNS, diabetes and ophthalmology.

According to Mr Albrecht, ‘changes have to be made in the scheduling of biosimilars development’. He added that ‘we are no longer working on adalimumab because we would not have gotten this product to market on time’.

It is not all bad news for biosimilars development at Stada though. According to Albrecht’s plan, there will be investments of more than Euros 100 million in the next three years in the biosimilars segment alone.

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1. GaBI Online - Generics and Biosimilars Initiative. Stada and Richter to collaborate on biosimilar development []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from:

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Source: Stada

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