In early June, Glenmark Pharmaceuticals announced the opening of a monoclonal antibody (mAb) manufacturing facility in Switzerland. Located in La Chaux-de-Fonds, the facility will supply clinical trial material to the Mumbai-based company’s antibody discovery and development unit in Switzerland. The new production unit will supplement the company’s research center, which has in-house capabilitiesfor conducting antibody discovery, cell line development, in vitro testing and characterization of antibodies.

Glenmark, which is seeking permission from MHRA, U.K. for conducting Phase I clinical studies for one of its mAb candidate, has been working on monoclonals for quite some time. The experimental GBR 900 is a first-in-class mAb targeting TrkA, the receptor of nerve growth factor to tackle chronic pain.

Glenmark’s biologics research center has several antibodies at various stages of development to deal with inflammatory, oncologic and respiratory conditions. GBR500, the most advanced mAb in its pipeline, has already been licensed out to Sanofi and is currently undergoing phase II studies. Another drug candidate, GBR 830, an anti OX-40 antagonist, is ready to enter clinical trials, company spokespeople said.

But Glenmark is hardly the only Indian firm to set its sight on the fast-emerging mAb market. A growing number of companies, including some without any biologics in their portfolios, are now in hot pursuit of the top-selling therapeutics as generic substitutes of bio drugs gain increasing acceptance worldwide. mAbs constitute a sizeable portion of the biosimilars market, which is forecast to touch $25 billion by 2020, according to IMS Health figures.

Foreseeing a boom, a clutch of generic producers started honing their skills in these highly specialized bio therapeutics years ago.
Biocon Ltd. joined the global league of mAb developers when it launched Biomab EGFR to treat head and neck cancer in 2006.
Now, biogeneric mAbs form the core of the company’s evolutionary innovation strategy. Releasing its second antibody drug to treat psoriasis in 2013, India’s leading biotherapeutics firm claimed itolizumab as the world’s “first-in-class” humanized anti-CD6 monoclonal antibody. The Bangalore-based company has an active pipeline comprising both proprietary and generic mAbs including BVX-20, a mAb that binds to CD20, which is currently undergoing clinical studies for non-Hodgkin’s lymphoma. Biocon is also developing monoclonal antibody fusion proteins for cancer.

Equipped with a large-scale multi-product mammalian cell culture facility, Biocon entered a partnership with Mylan in 2009 to take Indian-made generic versions of insulin, mAbs and other protein therapeutics to regulated markets such as the U.S.

Meanwhile, Merck KGaA has a full R&D cost-sharing agreement with India’s Dr Reddy’s to develop an array of biosimilar mAbs in the oncology segment. Under the terms of the pact signed in 2012, Dr Reddy’s will develop the drugs up to phase I. Merck will then take over manufacturing of the compounds and will be responsible for phase III studies. 

Mumbai-based Lupin Ltd. is reportedly looking for product-by-product partnerships to make a big splurge in the biosimilars market. So far, Lupin has developed a basket of 10 biosimilars, five of them in late-stage studies. The company’s advanced pipeline includes knockoffs of soon-to-be-off-patent blockbuster mAbs to treat cancer and arthritis.

In a reversal of sorts, Roche Holdings AG came calling India’s Emcure to forge an alliance to make biosims for its monoclonals such as Herceptin and MabThera. With the objective of taking control of the generic versions of these top-selling drugs, the Swiss drug maker agreed to transfer technology to the CMO in 2012.

Complex biologics will need strong manufacturing and commercialization capabilities. Apparently, such alliances prove a win-win for both partners, combining India’s cost-benefit base with major-league expertise and marketing prowess.

Competition is heating up as companies such as generics pioneer Cipla, Ltd. enter the fray. Cipla bought substantial stakes in MabPharm and Biomabs, biotech companies with manufacturing bases in Goa (India) and Shanghai. Traditionally a pure-play chem drugs maker, the Mumbai-based firm now aims to have a “disruptive” impact in the field of biosimilar monoclonal antibodies.
Avesthagen, Reliance Life, IntasBio, Zydus Cadila, Ranbaxy, Wockhardt are among others who have jumped on the mAb bandwagon. Surviving in this market won’t be easy. Industry experts wonder how many companies will ultimately make it to the finish line, given the sophisticated nature of biologics and the huge investment required. However, Indian generics companies are undaunted, and continue to push on.