Development of Affordable Biological Drugs in India
Globally, biologics are playing an increasing role in addressing unmet medical needs. The ability of biologics to target specific proteins makes them more effective treatments than small molecule therapies for a variety of medical illnesses and conditions. Biologic therapies such as insulin, erythropoietin, growth hormones and monoclonal antibodies are playing an invaluable role in treating serious illnesses such as diabetes, anemia, renal diseases and cancer.
Over 1.7 million new cases of cancer and over 880,000 cancer deaths are projected in India by 2020 as per the Indian Council of Medical Research (ICMR). The number of people with diabetes are expected to almost double to 134 million by 2025 from 72 million in 2017. In such a scenario, patients, caregivers and medical practitioners in the country need affordable access to safe, efficacious and high quality biologic medicines to fight chronic diseases.
However, developing biologics drugs is a capital intensive and research-intensive exercise with inherently long gestational time lines for product commercialization. Unlike small molecule generics, the development process of a biosimilar does not end at bioavailability and bioequivalence (BA\ BE) studies but extends to large and lengthy clinical trials, which add to the cost of development as well as stretch the gestational timelines for product commercialization.
Creating manufacturing infrastructure for biologics also involves a significant financial outlay. For example, it would take $200- 500 million to build a large-scale biologics manufacturing facility versus $30-100 million to build a small molecule manufacturing facility. Similarly, the cost of developing a biosimilar for global markets is estimated to be around $75-150 million in comparison to $2-5 million required to develop a generic.
Moreover, the end-to-end supply chain management from raw material procurement till finished goods dispatch is complex, with varied temperature requirements (-200 to 2500C). Once manufactured, storage and transportation of biologics require a robust cold chain infrastructure as wide fluctuations in temperature could lower the effectiveness of a product. Managing these complexities also significantly add to the costs of a novel biologic or biosimilar drug.
The costs involved in taking a biologic drug from ‘lab to market’ are orders of magnitude higher than chemically synthesized, traditional non-biologic generics.
The capital-intensive nature of the biopharma business means that there will be a handful of players in this space. However, imposing price controls may not be the answer to making these drugs affordable as biopharma companies need to make continued investments in manufacturing facilities required for biologics. Forced price cuts could make it unviable for these companies to operate and force them to pull out of the market, thus limiting choice and increasing risk of future supply shortages.
India will need to explore and implement broad initiatives to bring down the prices of these products. Initiatives to facilitate significant bulk purchasing by the government in order to meet the needs of patients who cannot afford biologics\ biosimilars could be a way to bridge the gap and create the potential for substantial additional savings through elimination of trade markups and through cost efficiencies due to economies of scale. Fiscal incentives for R&D-led companies working on developing biopharmaceuticals will also help them defray large costs and pass on the resulting benefit to patients.
With players like Biocon, Dr Reddy’s, Zydus Cadila, Lupin and Intas, India has the capability to be a leading player in the area of biosimilars just as it has gained recognition as the pharmacy of the world in small molecule generics. However, this success can be replicated in biosimilars only if leading pharma players are willing to make large investments in building high-end capabilities for developing biologics, coupled with global scale manufacturing facilities. Large-scale capacities can bring in economies of scale that drive down overall costs, enabling us to offer affordable access to biosimilars globally.
COO- Biocon Biologics
SHREEHAS TAMBE,COO- Biocon Biologics