Roundup of key biosimilar developments in Asia

A US$67 billion worth of biosimilar patents are forecasted to expire before 2020 and we are expecting to see more Asia pharmaceuticals gearing up their efforts to tap on the multi-billion dollar market opportunities.

At the start of 2015, we have round up a few key developments in Asia last year:
1. Zydus Cadila launched the first biosimilar for Adalimumab, the world’s biggest selling prescription medicine for millions of patients suffering from rheumatoid arthritis and other auto immune disorders. This new drug has been approved by Drug Controller General of India and will be marketed under the brand name Exemptia by Zydus Biovation, the new division of Zydus Cadila.

2. Celltrion from Korea announced approval for its cancer treatment biosimilar mAb Herzuma (trastuzumab) from the Ministry of Food and Drug Safety. Herzuma is a biosimilar of Roche’s blockbuster breast cancer treatment Herceptin (trastuzumab). Herceptin is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer, as well as HER2 positive adenocarcinoma of the stomach that has spread (metastatic or advanced gastric cancer).

3. Ranbaxy Laboratories launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar in India. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

China has also geared up their effort to be a part of the multi-billion-dollar Biosimilar market. In late 2014, China’s Center for Drug Evaluation (CDE) has published draft guidance for approval of biosimilars. The biosimilars guidance is expected to further improve regulations on technical requirements and the quality control of biologicals to streamline the approval process and speed up drug registration.

We are expecting to see more interesting development in Asia’s biotech industry this year. What is your thought?

If you are interested in finding out more about Asia’s biosimilar market, you might be interested in attending BioPharma Asia Convention 2015.

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