After opening the day on a positive note, the Indian share markets extended gains and are presently trading strong. Barring metal stocks, all sectoral indices are trading in green with realty stocks and IT stocks leading the pack of gainers.
The BSE Sensex is trading higher by 438 points (up 1.3%) while the NSE Nifty is trading higher by 126 points (up 1.2%). The BSE Mid Cap index is trading up by 1.9% while BSE Small Cap index is trading up by 2.4%. Gold prices, per 10 grams, are trading at Rs 39,824 levels. Silver price, per kilogram, is trading at Rs 37,660 levels. Crude oil is trading at Rs 3,959 per barrel. The rupee is trading at 64.14 to the US$.
In the news from the pharma sector. As per an article in a leading financial daily, Lupin’s joint venture (JV) YL Biologics (YLB) has successfully completed global Phase III clinical trial of its investigational Etanercept biosimilar (YLB113).
The Phase III study of YLB113 was a multinational randomized double-blind controlled trial of 52 weeks’ duration which included more than 500 patients with rheumatoid arthritis (RA) in 11 countries.
It compared YLB113’s efficacy and safety directly against Enbrel (of Amgen/Pfizer) which has a global market of US$11 billion and is a widely successful biologic agent globally used for the treatment of multiple autoimmune disorders including RA.
YLB is a joint venture between the company and Yoshindo in Japan.
The primary endpoint was an equivalent improvement in the rheumatoid arthritis, as measured by American College of Rheumatology 20 (ACR20) response rate. The ACR20 response rate of YLB113 has been found to be within a pre-defined equivalence margin that is expected by most advanced regulatory agencies for marketing authorization.
In addition, safety and immunogenicity (antibody formation) of YLB113 was also found to be similar to Enbrel indicating therapeutic equivalence.
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