Biosimilars -- a pre-defined moonshot sector for the Indian Biopharma industry is expected to grow over 30 per cent and above by 2047 but need governmental reforms to burgeon, indicated a Confederation of Indian Industry (CII) report released on Friday.
The report highlighted that a fast-track cell needs to be instituted in India to streamline processes and repeal redundant steps. Developing biosimilar medicines begins with a substantial investment in the specialised infrastructure, expertise, and technology required to create the product, verify that it is biosimilar, and ultimately maintain quality production.
Biosimilars are also called similar biologics. A similar biologic product is that which is similar in terms of quality, safety and efficacy to an approved reference biological product based on comparability, according to the Central Drugs Standard Control Organisation (CDSCO) and Department of Biotechnology (DBT) guidelines released in 2016. Biologics are derived through biotechnology and are products manufactured from living organisms. Biologics are designed in a way that they resemble the body's proteins.
The report highlighted that India’s dependence on imports for raw materials ranges from 20 per cent to 90 per cent based on the class of biosimilars and the intended market for the drugs.
“There is immense opportunity in expanding the entire lifesciences biosimilars innovation. Success eludes us. We have the ability for new drug discovery as well as achieve discovery of newer molecules. For this adequate funding and investments are required as well as tax rebates for R&D. Also there is a need for industry-academia collaboration for translational research,” said Satish Reddy, Chairman, Dr Reddy’s Laboratories at the CII organised 4th Life Sciences Conclave.
According to the India Bioeconomy report 2022 by the department of biotechnology, by 2025 BioPharma sector is expected to grow nearly 1.4 times to nearly $63 billion from $45 billion in 2022. It further said that the therapeutics segment is likely to create a BioEconomy of $15 billion from recombinant and biosimilar products.
“India-made biosimilars are getting accepted in developed markets like the USA and we can expect more nations to source cost-effective biosimilars in many disease categories as these global quality medical products demonstrate their efficacy and popularity in foreign countries,” the Bioeconomy report 2022 said.
The CII report pointed out that the time and cost of R&D have a significant effect on the cost of the biosimilar. Shortening or lengthening the time to market by even a couple of months can create big gains or losses. Industry experts consider India’s regulatory processes to be extremely slow as well as prohibitive for innovation.
“Even to experiment, the industry will need to get multiple time-consuming approvals. The biotech industry is regulated by departments and subcommittees under three ministries. Poor coordination between the ministries and redundant steps delay India’s regulatory processes,” it said.
Currently, a review for a biosimilar batch takes 20 to 25 days in the whole 45- to 90-day manufacturing cycle. To address these gaps, the report said, industry advisory boards need to be introduced to guide on matters such as identifying subject-matter experts, setting up process service-level agreements and SOPs, providing digital solutions, and identifying steps for self-certification.
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