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Biogaran expands its range of biosimilars

The French generic manufacturer Biogaran, a subsidiary of the Servier group, announced Monday extend its list of biosimilars with obtaining a positive opinion from the European Medicines Agency (EMA) for authorization to place on the market.

"This opinion serves as a recommendation to the European Commission that will grant the marketing authorization," said the group in a statement.

The biosimilar trastuzumab (Herzuma) is a replica of the anti-cancer biomedicine Roche, Herceptin.

Developed by its South Korean associate Celltrion, it will be indicated in early-stage breast cancer, metastatic breast cancer as well as metastatic gastric cancer, the statement said.

Biogaran will thus propose in 2018, after consulting the European Commission, "its 3e biosimilar monoclonal antibody and second monoclonal antibody in oncology after the success of the provision of Truxima (rituximab) in September 2017", used against blood cancers .

Biosimilars are biological drugs (produced by living organisms) that are similar to the original drug protein and whose patents have expired.

There are no generic biologics but only chemical drugs, hence the term biosimilars.

Biogaran had already launched in 2015 Remsima, a biosimilar of Remicade (group Johnson and Johnson), indicated in rheumatoid arthritis, Crohn's disease and psoriasis in particular.

Its president Pascal Brière said in September that its range of biosimilars could count "seven to eight" products by 2025 and represent 20% of its global turnover, against 2% currently.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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