Biosimilars to grow over 30% by 2047, says report

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Biosimilars to grow over 30% by 2047, says report

Biosimilars, a pre-defined moonshot sector for the Indian Biopharma industry, is expected to grow over 30 per cent and above by 2047 but needs government reforms, according to a report released on Friday by the Confederation of Indian Industry CII.

Investing in the specialised infrastructure, expertise and technology necessary to create the product, verify that it is biosimilar, and ultimately maintain quality production are some of the main investments in developing biosimilar medicines.

Similar biologics are also called biosimilars. A similar biologic product is similar in terms of quality, safety and efficacy to an approved reference biological product based on comparability, according to the CDSCO and Department of Biotechnology DBT guidelines released in 2016 by the Central Drugs Standard Control Organisation and the Department of Biotechnology DBT guidelines. Biologics are products made from living organisms and are derived from biotechnology. Biologics are designed in a way that they resemble the proteins of the body.

There is a huge opportunity for biosimilars innovation in the entire lifesciences. Success eludes us. We have the ability to discover new drugs as well as newer molecules. There are sufficient funding and investments for this as well as tax rebates for R&D. Satish Reddy, Chairman of the Dr Reddy s Laboratories at the 4th Life Sciences Conclave, said there was a need for industry-academia collaboration for translational research.

According to the India Bioeconomy report 2022 by the department of biotechnology, the BioPharma sector is expected to grow nearly 1.4 times to nearly $63 billion by 2025 from $45 billion in 2022, according to the India Bioeconomy report 2022. It said that the therapeutics segment is likely to create a BioEconomy of $15 billion from recombinant and biosimilar products.

Biosimilars made in India are 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 stated that the time and cost of R&D has a significant impact on the cost of the biosimilar. Shortening or lengthening the time to market can cause big gains or losses. Industry experts consider India's regulatory processes to be extremely slow and prohibitive for innovation.

The industry will need to get multiple time-consuming approvals to experiment. The biotech industry is regulated by departments and subcommittees under three ministries. It said that poor coordination between the ministries and redundant steps delay India's regulatory processes.

A biosimilar batch review takes 20 to 25 days in the whole 45 to 90 day manufacturing cycle. Industry advisory boards need to be introduced to guide on issues such as identifying subject-matter experts, setting up process service-level agreements and SOPs, providing digital solutions, and identifying steps for self-certification, according to the report.