Newspaper: The Economic Times
Section: Policy
Date: 18th Nov, 2010
Page: 11

Regulation to fuel biosimilars boom

RAJASHREE SHARMA Partner, Corporate Law Group

BIOPHARMACEUTICALS ARE CUTTINGedge medicines that offer hope to find new cures and treatment that will presumably make healthcare more affordable. The rising interest of biopharmaceuticals and generics companies has revolutionised biosimilar products. The country’s increasing prominence in biosimilars is evident from the number of such domestic products getting marketing approval. With the structure of the country’s biopharmaceutical industry developing, it will be the next big idea for techno-scientific entrepreneurship. So, we need the right strategic approach to grab an opportunity to become a global hub. Yet, there remains no formal regulatory framework for biosimilars in India, notwithstanding the World Trade Organization (WTO) membership and advances in compliance with international regulatory and intellectual property laws.

Biopharmaceuticals are medical drugs typically derived from living systems and produced using biotechnology. Biosimilars are biopharmaceuticals that are similar, but not identical, to an already-registered reference biological medicinal product in terms of quality, safety and efficacy. Biosimilars attempt to replicate a branded drug as closely as possible and prove to be highly similar to the product. Unlike the more common small-molecule drugs, biosimilars generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes.

The defining principles that have guided the country so far in regulating biosimilars will remain crucial to address the challenges still ahead. The challenge for the development of biosimilars arises from the fact that biologics are more complex than small-molecule and chemically-synthesised drugs.

The guidelines to create a pathway for biosimilar approvals is underway under the aegis of the department of biotechnology (DBT). These biodrugs will create a wave of low-cost competition in the domestic biotech industry. Moreover, the biosimilars will compete with leading R&D-based biopharmaceutical-makers. Significant competitive drugs such as human growth hormones, recombinant insulins, epoetin alfa, leukine and interferon-alfa have emerged as biosimilars. The new regulatory pathway for biosimilars is expected to catalyse competition in the biotech industry, which may drive the biopharmaceutical industry to deliver qualitative and affordable patient care.

The regulatory framework in Europe is more robust. The EU took the lead in implementing a regulatory pathway for the approval of biosimilars and adopted legislation in 2004 to bring biosimilars to market. The European Medicines Agency Evaluation of Medicines for Human Use (EMEA) further developed guidelines. The US Food and Drug Administration (USFDA) is also considering adopting the EMEA processes and has taken steps towards implementing guidelines on the approval pathway for biosimilars. In the US, Biologics Price Competition and Innovation Act (BPCI Act), 2009, establishes an approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) with a Food and Drug Administration-licensed biological product. India’s DBT has also started discussion with stakeholders for inputs on issues and challenges associated with the implementation of the biosimilar guidelines.

The WHO developed a guideline on similar biotherapeutics, or biosimilars, in 2009 that relied on European guidance, to assist countries to bring biosimilars to market. Similarly, Japan, Singapore and other countries have European-modelled biosimilar guidelines. India should also bring a transparent and predictable pathway in consonance with WHO and EMEA guidelines that enable them to compete with countries where biosimilar markets are highly regulated.

Once the pathway for biosimilars is laid out, biosimilars will have to undergo analytical studies to demonstrate highly similar or sameness to the reference product despite minor differences in clinically-inactive components. Also, it needs to follow the same prescribing instructions and indications as the reference product with regard to safety, purity and potency. The important task for the Drug Controller General of India (DCGI) would be to determine crossover studies such as interchangeability of a biosimilar.

Although there is no significant protection of a reference product such as data exclusivity in the country, submission of reference product data is a necessary part of filing to gain approval from the regulatory authority. India has, so far, demonstrated the greatest acceptance of biosimilars. The interest in biosimilars is spurred as domestically-manufactured biosimilars are widely accepted among healthcare professionals within the country. In recent years, many biosimilars have been approved for marketing in the country.

The DBT is also inviting proposals from domestic companies working on biosimilars under its Biotechnology Industry Partnership Programme (Bipp). This implies that the government will provide support to biotech companies on a cost-sharing basis for development of novel and high-risk futuristic technologies and to enhance existing R&D capacities for biosimilars.

As the country is aiming to grab a major share in the global biosimilars market in future, it needs to keep pace with big players and create financial backup and manufacturing knowhow to establish strong R&D capabilities. Increased use of biologic drugs is expected to help the region emerge as a potential market for budding biosimilar companies.