Biocon gets first European generics approval

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Biocon gets first European generics approval

Genéricos/Novedades | Posted 04/03/2016 0 Post your comment

India-based biologicals specialist Biocon announced on 15 February 2016 that it had received its first European generics approval for a generic version of Astra Zeneca’s blockbuster anti-cholesterol drug Crestor (rosuvastatin).

Rosuvastatin calcium tablets are indicated in patients with hypertriglyceridemia as an adjunct to diet and patients with homozygous familial hypercholesterolemia.

Biocon was the first generics company to receive a Certificate of Suitability (CEP) for rosuvastatin from the European Directorate for the Quality of Medicines & HealthCare (EDQM). CEP certification indicates that an active pharmaceutical ingredient (API) is suitable for use in medicinal products in the European Union.

The approval covers 5, 10, 20 and 40 mg tablets. Biocon gained the approval through the European Medicines Agency’s (EMA) decentralized procedure and says this will open the door to over 15 European countries and a market worth US$1.2 billion.

Biocon is better known for its candidate biosimilars and its partnership with US generics maker Mylan. The Biocon/Mylan partnership now has global phase III clinical trials ongoing for candidate biosimilars of adalimumab, bevacizumab, pegfilgrastim and trastuzumab [1]. The company also has six ‘similar biologics’, including insulin glargine, trastuzumab, epoetin alfa, human insulin, streptokinase and filgrastim, approved in India [2].

The company intends to expand its generics formulations business with a target of 20–25 filings over the next few years.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

References
1. GaBI Online - Generics and Biosimilars Initiative. Indian drugmakers make progress with candidate biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 4]. Available from: www.gabionline.net/Biosimilars/News/Indian-drugmakers-make-progress-with-candidate-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India

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Source: Biocon