Russian Blitz, Glenmark Peek Await Indian Biosimilars Arena
Executive Summary
Potential new entrants appear to be priming varied approaches to the competitive biosimilars market in India. While a full-fledged Russian challenge may be on the horizon as Biocad readies a basket of products for the Indian market, local firm Glenmark, which has been keen to stay focused on new biological entities (NBEs), now appears to be dipping its toe into the biosimilars segment.
Russia's Biocad, which was recently involved in a slugfest with Roche in Sri Lanka, appears to be readying a range of products including biosimilar versions of rituximab and trastuzumab for launch in India. (Also see "Roche Fears 'Real' Biosimilar Competition Says Russia's Biocad" - Scrip, 5 Jul, 2016.)
Biocad told Scrip that it had initiated additional clinical studies for rituximab (patient recruitment is almost complete, it maintained) and was "awaiting for registration" by the end of the first quarter of 2017.
Local studies are underway for trastuzumab; the Russian firm is looking to launch in India in the third quarter of 2017. Local partnerships are likely given the partner's "knowledge of the Indian environment" which will help Biocad in business development, it said.
But the Russian firm underscored that it had "no intention" to offer its monoclonal antibodies as "discount products" on the Indian market.
"The quality of our products in symbiosis with proper promotion will allow us to penetrate the market and hold position in the mass segment, i.e. satisfy needs of majority," Biocad told Scrip when asked about the pricing approach given existing biosimilar competition on the Indian market.
Biocad noted that the Indian market clearly shows "huge competition on every INN from the first sight", but added that after face-to-face meetings with the leading specialists in the country, it believed that only three brands of rituximab and two brands of trastuzumab cover most of the demand.
"The necessity of new product characterized by high quality and moderate price is crucial," the Russian firm said.
India's clinical trial registry also lists Biocad studies pertaining to products such as temozolomide and capecitabine, among others, suggesting a broader interest in the Indian cancer market, though the company offered no specific comment on these. Biocad, which has an office in Bengaluru, has no products on the Indian market currently; it expects to promote all its products through a partner's marketing network.
India's biosimilars market has seen a build-up in competition over the recent past. Legal challenges have also rocked the space.
Roche is currently engaged in a hotly contested case in India against partners Biocon Ltd. and Mylan concerning their biosimilar versions of Herceptin (trastuzumab). The Swiss multinational had earlier initiated a second brand program in partnership with the Indian firm Emcure Pharmaceuticals Ltd. for some of its products in India including Herceptin and MabThera (rituximab). (Also see "Roche draws emerging markets battle lines with launch of cut-price Herceptin and MabThera in India " - Scrip, 7 Mar, 2013.)
Roche's rituximab products are available as Ristova and a second brand Ikgdar (through the alliance with Emcure) in India. Dr. Reddy's Laboratories Ltd.'s Reditux (rituximab), which became the world's first non-original monoclonal antibody to be launched in 2007, emerged as the 300th largest brand on the Indian pharma market earlier this year, as per February 2016 data from AIOCD AWACS, a market research agency that tracks retail sales. (Also see "Four brands but no MabThera in Indian rituximab market flux " - Scrip, 3 May, 2013.)
Not A Major Play
Meanwhile, Glenmark Pharmaceuticals Ltd., which has thus far stayed away from a pure biosimilars play, has now submitted a phase III clinical trial protocol for trastuzumab in India, though the company maintains that NBEs and NCEs will continue to be its core R&D thrust.
A subject expert committee (SEC), which advises the Indian regulator on trial-related permissions as part of a layered approval process, had late last month deliberated on Glenmark's proposal and recommended, among others, that the test drug be supplied "free of cost" to the participants who are responders even after completion of the study till disease progression. The SEC also recommended that all trial sites have a medical oncologist, either as an investigator or co-investigator and that the DSMB [data and safety monitoring board] be constituted as per standard recommendations.
"The clinical trial permission may be considered subject to satisfactory review of physico-chemical, biochemical characterization of the proposed biosimilar drug and fulfilment of the regulatory requirements of approval of biosimilar drug in India," the SEC (oncology) said at its meeting on June 28.
Glenmark, however, told Scrip that it was focused on novel biologics and has a full-fledged R&D center for NBEs in Switzerland. The Mumbai-headquartered firm has five NBE molecules in clinical trials or ready to enter trials soon. These include GBR 1302, a HER2xCD3 bispecific antibody, Glenmark's first clinical candidate targeting oncology indications. (Also see "INTERVIEW: Glenmark's Buschle on how it hopes to 'BEAT' cancer" - Scrip, 21 Aug, 2014.)
"We don’t have any major play in [the] biosimilar front, but if there is any follow-on coming out of [the] novel biologics pipeline then we will consider it and will continue to evaluate it from a therapeutic area focus," Glenmark told Scrip.