Dr Reddy's bets high on biosimilars

By Emilie Reymond

- Last updated on GMT

Related tags Dr reddy European union

Indian drug maker Dr Reddy's is planning to launch one biosimilar
every year in the next few years, according to Indian media

The company said it has eight follow-on biologics in the pipeline, Indian newspaperThe Business Standard​ reported this week. In addition, the firm is investing up to $30m (€22m) to build a biomanufacturing facility in Hyderabad, India which is expected to be ready by 2009, the newspaper said. The country's second biggest pharma company was also reported to say it is in talks with European regulators to launch its biosimilar Reditux - a follow-on version of Rituxan (rituximab) - in Europe. Rituxan is co-marketed in the US by Genentech and Biogen Idec. The drug is used as a treatment of Non-Hodgkin's Lymphoma (NHL). Dr Reddy's launched the drug, which is a chimeric monoclonal antibody (MAb), in India in May and if approved in EU countries it would compete with Rituxan's European counterpart, MabThera, which is marketed by Roche in the region. "But it will take at least two years for us to get familiar with the different legal requirements on biosimilars in Europe and to wait for the US to come up with a clear regulatory framework for generic versions of biologics,"​ a spokesperson for Dr Reddy's told Biopharma-Reporter.com in an earlier interview. Reditux is the second biosimilar launched by Dr Reddy's biologics unit. The company sells Grafeel (filgrastim), a treatment that boosts white blood-cell production. Filgrastim is marketed by biotech giant Amgen as Neupogen. According to another Indian media story, the firm plans to launch Grafeel on the EU market too. "We have initiated negotiations with regulators in Europe to launch Grafeel, a drug used to reduce infections in patients with neutropenia,"​ Dr Reddy's chief operating officer Satish Reddy told India's The Economic Times​ yesterday. According to the newspaper, the company also said it would focus on the oncology area. Dr Reddy's was unavailable to confirm at the time of publishing. Biopharmaceuticals are currently protected form generic competition but a number of them are coming off patent soonk, which has attracted the interest of generic companies. The development of biogeneric products needs much greater financial resources than those required for the development of ordinary generics, because of the complex manufacturing processes, more extensive testing and arduous approval procedures. But a handful of Indian companies such as Dr Reddy's are developing the capability to produce complex biologics and generic versions of top-selling drugs and sell them at a discounted price in India, until now, while Europe has officially become the next target.

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