Companies with biologic drug interests are expanding fast, mastering the know-how, and setting their sights on lucrative biologics. Also, the sudden entry of certain steadfast generic makers who work with small molecule chemicals, are venturing out. Aurobindo Pharma, a producer of APIs and formulations, is a great example. A market leader in semi-synthetic penicillins, more than 85% of its nearly $2 billion revenues come from overseas trade. It received 19 final and three tentative approvals for ANDAs from FDA in 3Q16-17.

In February, Aurobindo made a formal foray into the biosimilars business by announcing the acquisition of a portfolio of four products from Swiss firm TL Biopharmaceutical AG. Aurobindo would market the drugs globally after developing them using the data provided by TL Bio. Aurobindo plans to start clinical trials of bevacizumab (Avastin), one of the three monoclonals acquired, this year. Also, Aurobindo is expanding its portfolio with eight more biosimilars as it builds on the first four products licensed from TL. The company has established an R&D center to support biologics development in Hyderabad, India and a proposed state-of-the-art manufacturing facility is expected to begin operations next year.

In another expample, Cipla revealed plans to set up a biosimilars facility at Durban, South Africa, investing about $90 million through its subsidiary Cipla Biotec. One of the world’s largest suppliers of anti-retrovirals, Cipla has a portfolio of more than a thousand products across various therapeutic categories. Cipla’s biologics facility is expected to be fully operational in 3Q18. The biosimilars produced at the facility will be for both state and private sectors, with the potential to export to markets in the U.S., EU and Asia, according to the company.

Hyderabad-based Hetero Drugs is another relatively new entrant to the field aggressively expanding on biosimilars. This contract services provider currently supplies 60+ APIs to the U.S. and European markets from its 18 facilities. Hetero launched its third biosimilar product—a version of bevacizumab—in India in July, last year. Clinical trials of adalimumab (Humira) and trastuzumab (Herceptin) are underway. Hetero’s plan is to commercialize a minimum of ten biosimilars by 2020.

The emerging biosimilar wave is increasing worldwide as cost-effective substitutes for expensive biologics and regulatory pathways are getting clearer. Reports show at least seven out of the top 10 bio drugs are facing threat from biosimilars in the near term. A recent study by KPMG forecasts the share of sales from biologics will go up to 27% in 2020 from 24% in 2015 as the global life sciences industry is gradually moving from chemical-based drugs to biologics.

For Indian players, the opportunity is going to be significant as $60 billion worth of biosimilar drugs are going off patent in the U.S. alone. To secure biologics skills and technologies, the firms are looking for acquisitions and alliances while establishing manufacturing facilities in other countries to access local and export markets.

Presently valued at $300-400 million, India’s market for biosimilars is growing at a compound annual growth rate of 14%, according to Brand India Pharma, an initiative led by Pharmaceutical Export Promotion Council and India Brand Equity Foundation, which comes under the Department of Commerce, Government of India. The new regulatory policy and affordability of biosimilars could speed growth. India’s contribution of biosimilars and non-original biologics is steadily going up. It is expected to be 2-5% of $221 billion in the coming days from around 0.3% of $46 billion in 2002, according to IMS Health data. 

At least a dozen Indian companies are now working on biosimilars with active development pipelines. FDA accepted Biocon’s BLA for pegfilgrastim for review, the company said in February. This is the second BLA from Biocon-Mylan biosimilar partnership pipeline being considered for review by the U.S. agency. The Ahmedabad-based Intas Pharma is in the process of seeking U.S. approval for pegfilgrastim biosimilar after successfully launching it in EU. Zydus Cadila launched a biosimilar of adalimumab recently in India. Zydus’s biosimilar pipeline consists of nearly ten molecules. In addition, Dr. Reddy’s, Lupin, Avesthagen, and Reliance Life Sciences are among the leading firms which have placed big bets on biosimilars.