Indian biotechnology industry stands tall in innovation and affordability. As human capital is expensive globally, the qualified human resources from India are now being leveraged for collaborative research and manufacturing.
With biologics positioned to address unmet medical needs, these targeted molecules impact underlying disease patho-physiology in unique ways, providing safe and effective treatments than small molecule therapies.
Biological products comprise vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins. Biologics comprise sugars, proteins, nucleic acids or complex combinations of these substances, or living entities like cells and tissues. Gene-based and cellular biologics, for example, are often at the forefront of biomedical research.
“These biological products often represent the cutting-edge of biomedical research, potentially offering the most effective means to treat a variety of medical illnesses and conditions that presently have no other available treatment. These are big and complex molecules, often 200 to 1,000 times the size of common small-molecule drugs. For example aspirin, a small-molecule drug, is made up of up 21 atoms, whereas the biologic drug etanercept, which treats rheumatoid arthritis and plaque psoriasis, comprises more than 20,000 atoms, said Biocon in its latest annual report.
Research and development-led innovation along with a range of technology-enabled transformations, are expanding the evidence-basis for interventions and bring in measurable health outcome improvements by 2020.
Biocon in its annual reported also noted that small molecule patent expiries will result in a larger impact across 2016-2020 than in the preceding five years (2011-2015).
Cancer treatments representing the largest category of 225 new medicines are likely to be introduced in the next five years. Over 90 per cent of the projected new cancer treatments are likely to be targeted therapies of which one-third could use a biomarker. Besides, an estimated third of cancer treatments could target rare cancers.
Given that biologics account for an increasing market presence, the future of the generic pharma industry is likely to be tied increasingly to these products. This year marks a full decade since the approval of the first biosimilar medicine in Europe. The approval of Sandoz’s human growth hormone (HGH) from the European Medical Agency (EMA) in April 2006 satisfied regulators that the biosimilar medicine offered a safe and efficacious alternative to the original biologic. In doing so, the treatment paved the way for other biosimilar medicines to enter the market across a range of therapy areas. Ten years on, it is clear that biosimilar products are set to play a vital role in the virtuous circle of pharmaceutical innovation and healthcare system sustainability, as per Biocon annual report.
The US biosimilars landscape holds significant promise with the USFDA defining the regulatory approval pathway for biosimilars which are cost-effective , counter-response to the significant price inflation in old and innovative pharmaceuticals. Considerable progress has been made in removing regulatory, legal and commercial roadblocks for these life-saving and cost-saving solutions, as per Biocon annual report.
The size of the biologics market for those products losing patent exclusivity between 2015 and 2020 is significant, including products in the two major therapy areas of inflammation like auto-immune and diabetes.
“We have seen across the EU that the use of erythropoietins (EPOs), granulocyte-colony stimulating factors (G-CSFs) and human growth hormone (HGH) have all increased following the launch of biosimilar versions. This increase in usage was heavily driven by the availability of biosimilars as well as other factors, such as expanded indications,” said Kiran Mazumdar-Shaw, chairman and managing director, Biocon.
We expect the same to play out for insulins and complex biologics like monoclonal antibodies. Besides the developed markets like the US and EU, markets in the developing world also offer a great opportunity for biosimilar developers. Making available these treatments to a patient pool who earlier either did not have access or had restricted access to these medicines will lead to better health outcomes in these geographies, said the Biocon chief.
Estimates suggest that the global biosimilars market could reach US$ 25-35 billion by 2020. The global & US biosimilar market analysis to 2021 report indicates a growing potential for biosimilars by 2019 when 50 per cent of the biologics market is forecast to belong to off-patent drugs. With the approval of the first biosimilar in the US in 2015 and the expected patent expiration of 12 biologics by 2020, biosimilars are expected to account for four to 10 per cent of the biologics market by 2020. Therefore, the biosimilar market has tremendous potential to be tapped.
The Indian biotech scene
India through companies like Biocon , which uses complex technology platforms to develop a portfolio of small molecules, novel biologics and biosimilars including monoclonal antibodies, rh-Insulin and analogs , will now make a significant impact in the global arena.
“We believe our value proposition built around differentiation and scale has enabled us to seek global leadership to provide access to affordable biopharmaceuticals for patients and partners across the globe. Our patient-centric approach and commitment to world-class quality have earned us the reputation of a credibly capable biopharmaceutical organization, said Shaw.
Biocon has scientifically rigorous, ethically compliant and structured preclinical and clinical development strategy to establish the safety and efficacy of its products. It has built state-of-the-art manufacturing facilities for both mammalian and microbial that are designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards and meet client requirements worldwide. Our global scale capacities for manufacturing high quality, affordable biologics have positioned us as the world’s fourth largest insulin producer, enabling us to address the growing needs of diabetes patients across the globe. We have successfully collaborated with multiple partners across geographies to establish our commercial footprint in nearly 120 countries, she added.
Bengaluru is a biotech cluster with companies led by Biocon , the largest player in the space with revenues to the tune of Rs. 3,143 crore in 2015-16, The others are Anthem Biosciences, Bhat Biotech, XCyton , azooka life sciences, Strand Lifesciences, to name a few.
Now azooka life sciences a speciality fluorescent dye company with focus on bringing safe fluorescent stains for application in biological sciences and genomics is ready with a patent pending food grade nucleic acid gel stain. Known as tinto rang, the nucleic acid gel stain is developed from a plant source. The company claims that it is the safest and fastest stain in the world market.
“We are seed funded and incubated by Society for Innovation and Development, Indian Institute of Science, Bengaluru. “Our focus is to develop safe DNA/RNA fluorescent stains for applications in biological sciences and genomics. Tinto rang is the first ever food grade nucleic acid gel stain making it the safest option currently available in the world” said Dr. J Fathima Benazir, co-founder and CEO, azooka life sciences in March this year.
Start-ups galore in biotech space
Karnataka is home to the largest number of start-ups in the country and is also the first state to announce a start-up policy besides being the world’s second-fastest-growing start-up ecosystem. In the biotech sector, start-ups have flourished in the Bangalore Bioinnovation Centre (BCC) and Centre for Cellular and Molecular Platform(C-CAMP) which is India’s premier technology and innovation hub.
In fact C-Camp also forms an important part of the Bangalore bio-cluster. It acts as an enabler of bioscience research and entrepreneurship by providing research, development, training and service in state of the art technology platforms.
Biocon too which is India’s largest and fully-integrated, innovation-led biopharmaceutical company is serving customers in over 100 countries. Some of the other leading start-up biotech companies in Karnataka are Bhat Biotech, which specializes in the design development, manufacture and marketing of diagnostic products and biotechnology based products. The company unveiled DNAmp the first indigenous PCR machine. XCyton Diagnostics, which developed a molecular diagnostic platform for critical infections ‘Syndrome Evaluation System’ (SES).
The 10 year-old Anthem Biosciences , which is a Contract Research Organisation (CRO) major, focuses on its core strength of chemistry and biology based actives. It is continuing the development of biologicals, probiotics, enzymes, nutritional products and active pharmaceutical ingredients (APIs). Another company is Bioneeds India, a CRO, offering discovery, development and regulatory service for pharma, biotech, agrochemical and medical device companies.
Strand Lifesciences is engaged in genomics research and Gangagen Biotechnologies , is developing products to control multiple species of bacteria pathogenic to humans, particularly antibiotic-resistant strains. Some of the incubated start-ups within C-Camp are Theramyt Novobiologics, BugWorks Research, Viravacs, Biomoneta, Sea6Energy and Cellworks Research India’s wet lab.
Pandorum Technologies, another biotechnology start-up working on tissue engineering, has developed artificial tissue that performs the functions of the human liver. These 3D printed living tissues enable affordable medical research with reduced animal and human trials; will eventually lead to full scale transplantable organs. The company is supported by grants from the Biotechnology Industry Research Assistance Council (BIRAC) and is located in the C-CAMP, Bengaluru Bio-Cluster.