At a time when the biosimilars market in India is expected to clock a 30 per cent growth rate between 2014 to 2018, pharma companies in Gujarat are increasingly focusing on this segment, eyeing the regulated markets in the longrun. Biosimilars are biological products that are similar or highly similar to the originator products and have similar level of efficacy and safety.
Gujarat-based firms like Intas Pharma, Cadila Healthcare and Torrent Pharmaceuticals have come up with biosimilar products in the last few years, and are readying a pipeline for the future. For example, Intas has nine products already in the market, and recently launched a biosimilar to Lucentis (ranibizumab), which is used to treat degenerative conditions of the eye called Razumab. It would be 25 per cent cheaper than the imported Lucentis.
The company claimed that it is the first company globally to develop and launch a biosimilar version of ranibizumab, which is a therapeutic antibody fragment designed specifically for treating degenerative conditions of the eye. As Binish Chudgar, vice-chairman of the company explained, the company already has a host of products in its pipeline, like Peg GCSF, which is probably its next launch. He admitted that cracking the regulated markets for biosimilars is not an easy task. "Our target market is the European Union while cracking the US would take some time. We are aggressive on oncology products, we also give some of our products to third party agents for marketing, like erythroprotein, to increase the reach of the product," he said.
A Mumbai-based analyst explained that in case of biosimilars, the value erodes very fast, and, hence, the growth in the domestic market is in single digits. "Companies are readying infrastructure and pipeline as it is going to be a lucrative market in the longterm.
As the efficacy of the biosimilar or biologics is established against chemical drugs, the demand is set to rise. Moreover, patent expiries in regulated markets is expected around 2017, when a lot of opportunities would open up. For the time being, the companies are targeting the emerging markets," he said.
Chudgar too said that their latest opthalmology product would be targeted for the Rest of the Word (RoW) markets. Another leading Gujarat-based company Cadila Healthcare (Zydus Cadila) had launched a biosimilar version of dalimumab last year December to treat auto immune disorders, like rheumatoid arthritis, etc.
The biosimilar of Adalimumab is a part of Zydus' robust biologics programme, which has the largest number of monoclonal antibodies under development in India. The drug would cost one-fifth of the original, and the company's commitment to the segment comes out in the fact that the therapy will be marketed by Zydus Biovation - a new division.
The group has an R&D pipeline comprising of at least 24 biologics, which include biosimilars and also novel biologics that are targeted at disorders like infertility, cancer, stroke etc. According to Pankaj Patel, chairman and managing director of Cadila Healthcare, of these, around 14 are biosimilars, and there are four novel biologics.
Patel added that the company's strategy would be to launch these products in the domestic market first, and then take it to emerging and regulated markets. As such, the share of biologics is not very high in the overall turnover of these companies. Chudgar said, "It is less than 10 per cent of our Rs 2,400 crore turnover, around Rs 200 crore sales come from biopharma products." Patel admitted that for them it is roughly around 3-4 per cent of their turnover. However, analysts point out that companies are basically preparing themselves for the patent expiry in regulated markets.
Around the same time when Zydus launched its biosimilar version ofAdalimumab, city-based Torrent Pharmaceuticals entered into an exclusive licensing agreement with Reliance Life Sciences for marketing three biosimilars in India — Rituximab, Adalimumab and Cetuximab. While Rituximab and Cetuximab cater to the oncology segment and are used in the treatment of various cancers such as leukaemia, lymphoma, colorectal, head and neck, Adalimumab is the therapy for the treatment of auto-immune disorders such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.
According to the terms of the agreement, Reliance Life Sciences will manufacture these products at its facility in Navi Mumbai and supply to Torrent Pharma for a period of 10 years, after obtaining all necessary regulatory approvals.
An email sent to the company did not elicit any response.
Companies like Lupin, that have manufacturing presence in Gujarat too are active in this space.
Lupin has 10 Biosimilars under development out of which two have received approval and is preparing for the launch.