Biosimilar drugs are the new buzz words for the Indian pharma industry. They offer a new market and growth opportunity. Compared to chemical generics, biosimilar drugs are structurally large complex molecules manufactured by a complex process, making drug development long – 6 to 9 years – and expensive, at over US$ 100 million. However, the Indian market is flooded with over 70 biosimilars. Success in the Indian market is a likely outcome of several local conditions: 1) Indian regulations for biosimilars are not as demanding as US and European regulations; 2) Indian prescribers probably have limited understanding of the key concepts of biosimilarity; and 3) The common medical practice of prescribing cheaper drug brands due to cost considerations or commercial benefits. But price wars will make the Indian market commercially unattractive. The Indian pharma sector is therefore looking for greener pastures in the US, where the biosimilar market is growing at a healthy CAGR of 33% and is expected to reach $45 billion by 2025. However, the US biosimilar market is quite tough to enter, as there are multiple challenges – stringent regulations, big pharma competition and consumer perceptions.
US FDA regulations require that a biosimilar should be highly similar – with no clinically meaningful differences – to the reference biologic product in safety, purity and potency. The biosimilar development process should be stepwise, providing a totality of evidence based on a comparison of the biosimilar and the reference product during analytical, preclinical and clinical studies. At each step, the sponsor should evaluate and reduce the level of residual uncertainty about the biosimilarity of the product to the reference product. FDA also requires additional alternating or switching clinical studies to approve interchangeability between the reference and the biosimilar product. To meet these rigorous regulatory requirements, the company should invest in a robust, science-based and data-intensive development process, state-of-the-art technology and highly sensitive analytical techniques. Hence, the majority of the companies developing biosimilars are big R&D-based international brands. American consumers – payers, prescribers, and patients – are unlikely to adopt biosimilars without substantial cost savings. As there are not many biosimilars in the US market, the prescribers’ knowledge of crucial concepts – regulatory pathways, safety and immunogenicity, and interchangeability – is inadequate. Hence, they are less likely to prescribe a biosimilar in stable patients with an unpredictable disease course, e.g. cancer.
In the US, Indian biosimilars are likely to be considered biomimetics as they have not undergone a strict development and regulatory process. Considering the cost and expertise requirements, Indian companies have joined hands with international generic companies to develop new biosimilars. The international partner carries out critical analytical, preclinical and clinical studies, while the Indian partner works on a cost-saving manufacturing process. However, FDA pre-license inspections of Indian companies have detected deficiencies in the manufacturing processes for biosimilars, delaying regulatory approvals of new biosimilars. EU regulators have not approved Indian biosimilars due to major GMP deficiencies during regulatory inspections.
Unless Indian pharma develops international level capabilities for pre-clinical and clinical studies and establishes quality and credibility in the manufacturing process for biosimilars, it won’t be able to succeed in well-regulated international markets and win the global contest.