The products concerned are ‘similar biologics’ of Roche’s arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab), AbbVie’s autoimmune disease treatment Humira (adalimumab), and Bristol-Myers Squibb/Eli Lilly/Merck’s colorectal (bowel), lung and head and neck cancer treatment Erbitux (cetuximab).

Under the terms of the agreement, Reliance will develop and supply (for a period extending up to 10 years) the ‘similar biologics’ to Torrent after obtaining all necessary regulatory approvals. The products are at various stages of development/regulatory approval status.

Other than Reliance, Torrent will be the only other company to market these ‘similar biologics’ in India. The licensing agreement is expected to significantly boost Torrent’s presence in the oncology and dermatology segments in the coming years.

This is not Torrent’s first foray into the ‘similar biologics’ market. The company also states that it has launched a ‘similar biologics’ of darbepoetin alfa in India under the brand name Darbatitor.

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.

Related article
‘Similar biologics’ approved and marketed in India

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