From biosimilars and vaccines development to orphan drugs, stem cells, and biologicals, Indian companies reverberate the Union government's ‘Make in India’ initiative.
Companies from Biocon, Serum Institute, Anthem Biosciences, Panacea, Dr. Reddy’s Labs, Wockhardt, Glaxo SmithKline, Bharat Serum & Vaccines, Novozymes, Indian Immunologicals, Shanta Biotechnics and Reliance Lifesciences, to name a few, are the ones who have jumped into the 'Make In India ' bandwagon.
Biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing make-up the canvas of Indian biotech industry.
According to Kiran Mazumdar-Shaw, chairman and managing director, Biocon, technology is revolutionizing life sciences by decoding diseases at the cellular and genetic level and helping usher in safer and more effective therapies for patients. Today’s medical paradigm is rapidly evolving from a ’one size fits all to a customized solution of the right treatment for the right patient at the right time’ with an aim to minimize side effects and maximize positive outcomes. These advances in understanding disease mechanisms, diagnosis and treatment using genomics and cell biology are coinciding with the rapid spread of non-communicable diseases (NCD).
Biologics like insulins and monoclonal antibodies have emerged as a class of highly effective transformational life-saving drugs targeted at chronic diseases like diabetes and cancer. Biologics differ from chemically synthesized drugs in that the regulatory, clinical and development requirements are considerably more exacting, making them 20-50 times more expensive than conventional drugs. The high cost of biologic therapies pushes them out of the reach of many patients, especially those in LMICs( lower middle income countries) like India where drug regimens can cost several months’ wages , making the treatment of chronic disease like diabetes and cancer unaffordable, she added.
“We are fully geared to address the unfolding biosimilars opportunity in emerging markets and through market filings in key developed markets. We believe that FY17 will set the stage for Biocon to emerge as a leading global player in the realm of biosimilars. The Generic Formulations business is expected to gather momentum in FY17 as we intensify our focus on being a vertically integrated player in the niche space of difficult-to-make and technologically intensive generic drugs, stated Shaw in her annual report 2016-2017.
The Indian biopharmaceutical industry is recognised for its low cost, high-quality production and regulatory compliance. The country is known for its R&D and manufacturing capability to meet challenges of the prevailing chronic diseases, drugs going off-patent and entry into new markets. Besides, it is a bioprocess solutions provider, ample assignments in clinical research and contract manufacturing. There are also global analytical instrument manufacturers like Water and Merck Millipore. There is also a strong presence of domestic biotech companies focusing on diagnostics like Bhat Biotech and XCyton. There are also companies like Strand Lifesciences and MedGenome which are focusing on a new generation of healthcare solutions driven by genetic insights into disease. Research companies like Gangagen known for its phage-based therapies and Connexios Life Sciences , an early stage drug development company besides start-ups like Genotypic, Theramyt Novobiologics and Hyderabad-based Tergene Biotech to name a few are now exploring ways to improve global competitiveness and move up the value chain.
The way forward is to identify new markets, increase product offering, look at mergers and acquisitions to consolidate their market in order to compensate the sluggishness in the domestic market due to black swan events like demonetisation and the entry of President Trump, said the industry.
Noteworthy developments
Early this month, Biocon and Mylan announced that the USFDA accepted the biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
Institute of Bioinformatics and Applied Biotechnology (IBAB), Bengaluru and the Harvard South Asia Institute, Cambridge, MA have collaborated to drive research on neurosciences. Through a B4 program both IBAB and SAI are working to create a scientific research corridor to engage scientists from India and Harvard through exchange programs.
As a first step to bolster research in neurosciences, Harvard South Asia Institute has stressed the need to engage faculty and students through interdisciplinary programs to advance and deepen the teaching and research in neurosciences. “With two billion people facing similar challenges throughout South Asia, there is a critical need for solutions and systems to support such a significant global population, said Prof. Venkatesh Murthy , Professor of Molecular & Cellular Biology Director of Undergraduate Studies in Neurobiology, Harvard University.
Union government support
To enable technology innovators and entrepreneurs to pursue a promising technology idea, and establish and validate proof of concept (POC) for the idea, the Biotechnology Industry Research Assistance Council (BIRAC) under its Biotechnology Ignition Grant (BIG) scheme, invited research proposals from potential entrepreneurs from biotechnology for igniting new ideas from biotechnology start-ups, entrepreneurs or academicians, scientists, researchers, PhDs, medical degree holders and biomedical engineering graduates.
The scheme is aimed for high level of innovation in the biotechnology sector and does not support basic research projects. It will only support up to proof-of-concept stage and grant-in-aid limited upto Rs. 50 lakh for the period of 18 months.
Vaccine capability
There is now a strong global consensus about new and sustainable partnerships models that are needed for R&D of vaccines to contain outbreaks of epidemics of known and some possible diseases.
India is a well-known, reliable producer of high quality and affordable vaccines of several life-threatening diseases and it is no surprise that globally one in every three children is immunized with Indian made vaccines. The country’s vaccine industry has both the capability and capacity of tackling situations at a short notice, said Dr K VijayRaghavan, secretary, department of biotechnology (DBT).
Going forward, the Union government through DBT and the Indian vaccine industry would work together to protect Indian citizens and others from potential epidemics. SARS, Ebola, Zika are diseases that have been in the news not only for the fatalities they cause but also for the fact that the outbreaks have been sudden and vicious.
According to Serum Institute of India, Pune, it is now the world’s largest vaccine manufacturer by number of doses produced and sold globally which is more than 1.3 billion doses. In 2013, the company and Bilthoven Biologicals B.V, The Netherlands, endeavoured to support the programme to reach the Global Polio Eradication Initiative [GPEI] Endgame Strategic Plan 2013-2018, by substantially reducing the price of IPV from the prevailing price available in the market, in the recent tender bid with UNICEF. This is for the first time that the two companies have joined hands together to make IPV available to UNICEF at a subsidized rate, which resulted in triggering a global reduction in price of IPV.
Ahmedabad- based Hester Biosciences, a Rs. 100 crore plus leading animal health care company is the country’s second largest poultry vaccine manufacturer. Apart from poultry vaccines, the company has recently forayed into large animal vaccines, poultry health products and large animal health products.
The four verticals put together will underpin Hester’s identity as a strong animal health company, addressing all segments in the animal health care sector.
In February, 2016, the Hyderabad -based vaccine maker, Bharat Biotech, announced its plan to come out with a breakthrough solution for the much feared mosquito spreading Zika virus. The company is expected to take two years for producing the vaccine on a commercial scale.
Indian Immunologicals, a wholly owned subsidiary of the National Dairy Development Board, which is a veterinary biological market major , in October 2016 launched CYSVAX vaccine to fight tapeworms in pigs. The recombinant porcine vaccine also has the potential to significantly reduce the incidence of epilepsy in humans.
The company collaborated with Dr. Marshall Lightowlers, University of Melbourne, Australia and GALVmed (Global Alliance for Veterinary medicine) to develop CYSVAX. It obtained the license to manufacture and market this product after conducting extensive field trials in India and many other countries such as Spain, Peru etc. Trials are also underway in Nepal, Zambia, Uganda and Tanzania. The company claims that it is the world’s first vaccine to fight against tapeworms in pigs.
Visible trends
The Centre for Cellular and Molecular Platforms (C-CAMP), an initiative of the DBT along with the institute for Stem Cell Biology and Regenerative Medicine and National Centre for Biological Sciences, forms the bio-cluster in Bangalore and as a part of its mandate focuses on start-ups by giving access to high-end infrastructure, expert guidance and cutting-edge technology.
There is ample activity on the life sciences start-ups front which are engaged in indigenous research and manufacture of diagnostics, drug development and devising advanced manufacturing technology. Some of these are Hat Biotechnology, XCyton, Affigenix Biosolutions, Biomoneta Research, Bugworks Research, Coeo Labs, Df3d, InnAccel, Kinome, Pharma, Module Innovations, Nuture Earth, Plasmatech Solutions, Sea6 Energy, Shilps Sciences, String Bio, Thermayt Novobiologics, Unilumen, Photonics, Viravecs, Lybrate to name a few.
With the positive environment for funding from private equity and venture capitalists, highly qualified young professionals now prefer to form start-ups, according to Prof. Vijayaraghavan.