Indian drugmakers muscle in on biosimilars development


Therapeutic proteins (biosimilars) manufactured from natural sources and providing solutions for several unmet clinical needs are the next big thing in India. Adoption, growing investment and deal making in the global arena has got several Indian companies tuning in to biosimilars, reports The Pharma Letter’s India correspondent.

Though the high price of biologic therapies is a great burden on healthcare costs globally and a majority of patients in India still cannot afford these drugs, Indian drug majors are stepping up investments to tap the growing opportunities overseas.

While Cipla recently signed a memorandum of understanding to set up South Africa's first biosimilars manufacturing facility at a cost of nearly $91 million, Intas Pharma is gearing up for US approval for its Neulasta (pegfilgrastim) biosimilar this year.

Amgen’s Neulasta is the company's second largest selling white blood cell boosting medicine, and reportedly brought in sales of $1.15 billion in the second quarter of this year. Intas is set to launch a copy of the drug in the US market, which it has developed with Canada's Apotex.

The Ahmedabad based Intas is a privately held company, and backed by two leading financial investors, Temasek and ChrysCapital. It has the largest commercialized portfolio of biosimilars in India and is the first Indian drug company to launch a biosimilar in the European Union.

The company is looking to spend around $30 million for research into trials of biosimilars. With an annual turnover of $1 billion, Intas draws 60% of its annual revenues from international operations.

The interest of Indian drug companies in this segment is evident as drugs worth $90 billion are set to go off patent in the Europe and the USA over the next 10 years.

Biosimilar wave
Biosimilars are an attractive opportunity, with analysts expecting the global market to be close to $240 billion by 2030. At that time, it is estimated that close to half of this market size would be in emerging economies, with the Indian market capable of reaching $40 billion.

More than 10 large pharmaceutical companies in India have focused investments on biosimilars and the country boasts having a very active development pipeline. More than 60 biosimilar drugs are already approved in India.

India's Biocon is the only well-equipped player to participate in first wave of biosimilar launch, with four advance stage products in the pipeline. Roche’s Herceptin (trastuzumab) is one such drug, whose patent expired in 2014.

In August, Mylan and Biocon said the European Medicines Agency has accepted for review Mylan's marketing application for biosimilar trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan's application for biosimilar pegfilgrastim was accepted for review by the EMA. Mylan and Biocon, which have co-developed the biosimilar, anticipate that this may be the first trastuzumab biosimilar filing accepted by the EMA for review.

Globally, there are 37 biosimilar version of the Herceptin drug in clinical pipeline. Currently, there are four biosimilars in Phase-III trials which are expected to be commercially available over the next five to eight years.

Three biosimilar versions of Herceptin are commercially available in India for the treatment of breast cancer. In May this year, the Indian government capped the price of trastuzumab at 25% lower than the innovator Roche's drug.

Many players in the sector
Biocon has four biosimilars: trastuzumab, adalimumab, pegfilgrastim and insulin glargine. Biologics have registered growth of 26% for the company, based on healthy supplies of trastuzumab and insulin glargine in the emerging markets.

Two of its biosimilars - trastuzumab and pegfilgrastim - are also under review by Europe’s EMA. Biocon has indicated it will be filing at least four biosimilar applications for review in the Europe as well as the USA. The four biosimilars have an addressable market size of $30 billion.

On the other hand, Dr Reddy's too has a wide portfolio, with products like rituximab, filgrastim, darbepoetin and others. Zydus Cadila has nine biosimilars and recently launched the world's first biosimilar version of arthritis drug adalimumab.

Steady increase In India’s share of biosimilars
India's share of biologics has been steadily increasing over the years. In 2002, it was 11%, while in 2007 it was around 15%, according to data from IMS Health. By 2012, India's share of biologics jumped to 18%, and by early next year, it is expected to be 20%.

Similarly, the country's share of biosimilars and non-original biologics is also on the rise. In 2002, it was around 0.3% of $46 billion, while in 2007 it was 0.5% of $106 billion, IMS Health data showed. In 2012, it was 1% of $169 billion while by next year, it is expected to be 2-5% of $221 billion.

Expiration of patents and greater regulatory support has only aided the trend. With patents for over six top selling biologics like Humira, Avastin, Enbrel, Rituxan/MabThera, Herceptin and Remicade expiring between 2015 and 2020, it allows manufacturers of biosimilars to seek US Food and Drug Administration approval for generic biologics.

Globally, more than 160 biosimilars have been reported in different stages of development for these six best-selling biologics.

Gautam Kothari, associate director of research and equity firm Equirus Capital, says biosimilars tend to offer a higher margin, and that biologics' patents worth $55 billion are set to expire by 2020.

Indian companies have taken note. The Indian biosimilars industry was close to $300 million in 2015 with domestic sales pegged close to $250 million. Sales have been growing at an annual rate of 14%.

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