Biosimilars bring in some great tidings for the new year and perhaps for the new decade. The Indian pharma industry is abuzz with biosimilar stories. So far, Indian companies have launched 123 biosimilars and currently have a development pipeline comprising 201 molecules, according to a new report released by Clarivate Analytics.

Presently, one in every three new drugs approved is a biotech drug. Of the top 10 blockbusters in 2018, only two were small molecule therapeutics and eight were biologicals. No wonder, if the cost-effective versions of innovator biologics have become the new mantra for an industry that has already earned a repute producing cheaper copies for almost every small molecule pharmaceutical product.

Companies from India have made some big forays into the biosimilars space, despite the complexity and heightened costs associated with these living-cell derived products.

They are among the foremost entrants in the global biosimilars business. Biocon Biologics, a subsidiary of Biocon, has got biosimilar products approved in various developed markets including the U.S., the EU, Japan and Australia.

Unsurprisingly, the biggest headline on this front comes from this biotherapeutics major itself. In early January, Biocon said that True North, a private equity firm, would buy a 2.5% stake in Biocon Biologics for a sum of $75 million.

The announcement came close on the heels of Biocon’s successful commercialization of the company’s second biosimilar, trastuzumab-dkst (Ogivri), in the U.S. market. Co-developed by Mylan, Ogivri was the first biosimilar trastuzumab approved by the U.S. FDA and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC), Biocon said. The companies launched biosimilar pegfilgrastim in 2018.

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. The fresh investment from True North will boost Biocon Biologic’s market value to around $3 billion.

According to the company, this investment is an endorsement of the value that Biocon has demonstrated as a global biosimilars player. Apart from the U.S., Biocon has commercialized its trastuzumab biosimilar in over 80 markets worldwide.

Biocon plans to broaden its pipeline and expand manufacturing capacities to increase the company’s commercial footprint.

Currently, the company claims to have one of the largest global biosimilar portfolios with products across therapeutic categories such as oncology, immunology, rheumatology and diabetology. The product basket includes the molecules being developed in association with Mylan and Sandoz.

Biocon and Sandoz, the generics arm of Novartis, reached a pact to jointly invest and co-develop, manufacture and market, a new range of biosimilars in immunology and cancer for the global markets in 2018.

Last October Biocon Biologics signed a licensing agreement with Just-Evotec Biologics, wholly owned by the Hamburg head-quartered Evotec, for an early stage, preclinical biosimilar.

Biocon has built huge state-of-the-art biomanufacturing facilities for insulins and monoclonal antibodies in India and Malaysia.

The company targets a revenue milestone of $1 billion by FY22 from biosimilars business.

The global biosimilars market is expected to grow to $23.6 billion by 2023, from $5.9 billion in the calendar year 2018, backed by several biologicals losing patent protection globally, says a report by Icra Research, a credit rating agency.

The global market is on the cusp of exceptional growth and presents attractive opportunities for pharmaceutical companies in the years to come.

Select Indian pharma companies with strong R&D capabilities will be in a position to exploit these opportunities in the key markets of the U.S., Europe and the rest of the world, the report adds.

Almost all leading companies in India have bio drug portfolios. Foreseeing the unfolding opportunity, some early movers have made significant investments into developing biosimilar products.

Intas Pharmaceuticals, for instance, was the first Indian company to get a biosimilar (filgrastim) launched in the EU in 2015. The Ahmedabad-based biotech firm, which commercialized pegylated G-CSF biosimilar in Europe 2018, has lined up three more in the pipeline for Europe. The company is also hopeful of getting its first biosimilar approved in the U.S. this year.

Meanwhile, Lupin Ltd., a comparatively late entrant in the field, has slated several biosimilars for launch in the EU and other markets eyeing a 10% market share over the next five years.

Dr. Reddy’s Laboratories, Zydus Cadila, Reliance Life Sciences, Aurobindo, Glenmark, Emcure, and Alkem Labs are among the leading players in the growing list of companies aggressively pursuing biosimilars.