Lupin, YL Biologics get nod to sell rheumatoid arthritis drug in Japan

Pharmaceutical major Lupin said that YL Biologics Limited, its newly formed joint venture with Japanese pharma company Yoshindo Inc has received approval from the Pharmaceutical and Medical Devices Agency (PMDA) for sales of a biosimilar version of Amgen Inc’s Etanercept in Japan.

Etanercept, sold under the brand name Enbrel or Benepali. is a biopharmaceutical drug used for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. It works by blocking tumor necrosis factor alpha (TNF alpha).

Biosimilar medicines are follow-on versions of original biological medicines, developed independently after the expiry of the patent protecting the original product.

Lupin is one of the world’s biggest makers of generic drugs, and sells both branded and generic formulations, biotechnology products and pharmaceutical ingredients globally.

It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.