Biosimilars manufacturing in India is readying to take a big leap even as the country plans to realign its bio drug development policy.

A slew of regulatory reforms including an amendment to the Guidelines on Similar Biologics is being weighed by the policymakers factoring in the spectacular achievements in the field of biosimilars development in the country.

The Indian biotherapeutics industry has an impressive track record and it made it easier to master the know-how to make replicas of complex biologic products quite early.

India’s Biocon Ltd. launched trastuzumab-dkst in the U.S.market through the company’s overseas partner Milan NV, in December 2019. In this case, it is worth noting that the Oncologic Drugs Advisory Committee (ODAC) of the FDA gave a unanimous nod to the first similar biologic made by an Indian company.

Much before securing the approval in the U.S., Biocon had successfully launched this biosimilar version of Roche’s blockbuster Herceptin in India. India approved its first biosimilar, a hepatitis B vaccine, way back in 2000 making it one of the first countries in the world to use these generic versions of biologics. Today, over a hundred bio firms vie for manufacturing an array of biosimilars in India that include insulins, mAbs and recombinant proteins. Apart from that, the country is the largest supplier of vaccines in the world.

The rising number of players and the increasingly complex processes involved in the making of these naturally-derived products made India’s regulator take a fresh look at the “Guidelines on Similar Biologics; Regulatory Requirements for Marketing Authorization in India,” which were formulated in 2012.

Designed by the Central Drugs Standard Control Organization (CDSCO) in association with the Department of Biotechnology (DBT), the guidelines lay out the norms for manufacturing biosimilars as well as their quality, safety, and efficacy. They also stipulate due processes for the pre- and post-marketing regulatory requirements for biosimilars.

DBT, in the meantime, monitors the development and preclinical evaluation of biologics, through Review Committee on Genetic Manipulation.

In 2016, CDSCO revised the guidelines adding some important provisions to address the lingering concerns about the safety of “similar biologics” produced in India. The modified guidelines make an attempt to align with other international agencies such as EMA and WHO, rather than sticking to India-specific practices to establish the similarity of the molecular and quality characteristics of a biosimilar with reference products. In addition, it makes the biopharmaceutical producing company conduct a phase IV study with a minimum of 200 patients within 2 years of getting approval for marketing.

Also, in cases where phase 3 data on the Indian population is necessary, a single-arm study in at least 100 evaluable subjects may be carried out in the most sensitive indication “to address any residual uncertainty.” Wherever the phase III trial is waived, the immunogenicity should have been gathered in the PK/PD study and will also need to be generated during the post-approval phase IV study, according to the modified guidance.

Again, through the proposed reforms, the policymakers aim to foster an environment more conducive to the accelerated development of these products and help the industry to strengthen its position in the huge, rapidly emerging biosimilars market.

Globally, biosimilars continue to post monumental growth, with estimates suggesting that the sales topped $15 billion in 2020, representing a compound annual growth rate of 56% since 2015. Reports indicate the market is set to keep up its double-digit growth, doubling in size by the next couple of years.

According to a GlobalData report, “Future of Pharma—Looking Ahead to 2022,” biologics are forecast to significantly overtake innovative small molecules by sales over the next five years, with biologics forecast to have $120 billion greater sales than small molecules by 2027.

Leading players have already thrown down the gauntlets. Biocon subsidiary Biocon Biologics’ $3.3 billion deal with Viatris to acquire the U.S.-based company’s biosimilars business in February, offers an example. The manufacturing sector is poised to see more actions as other medium/small level CMOs/CDMOs are also in the process of either expanding or augmenting their capacities and service capabilities, reports show.

Although biologics are one of the top-selling drugs worldwide, the exorbitant cost of these medicines are a forbidding factor making them unaffordable and inaccessible to many patients.

A recent decision by WHO to amend guidelines for evaluating biosimilars to waive off phase III clinical trials for biosimilar products, is seen as a step towards addressing the cost factor.