Published on: July 28, 2025

Biosimilars have emerged as a game-changer in the healthcare landscape, offering a promising solution for patients with complex diseases such as cancer, muscular degeneration, chronic skin diseases, bowel diseases, diabetes, arthritis, and kidney conditions. As highly similar versions of original biologic medicines, biosimilars hold the key to expanding access to life-saving therapies and reducing healthcare costs.


The Promise of Biosimilars: Affordability and Accessibility

Biologic medicines, derived from living organisms, are often the only effective treatment for many severe conditions. However, their high-cost limits accessibility to a significant portion of the population. Biosimilars offer an equally effective yet more affordable alternative, providing a critical solution to this problem.

For instance, originator biologics like Pertuzumab (for breast cancer), Pembrolizumab (for multiple cancers like melanoma and lung cancer), Atezolizumab (for bladder, liver, breast, lung cancers), Obinutuzumab (for blood cancer), Durvalumab (for NSCLC, biliary tract, liver, and endometrial cancers), and Trastuzumab Deruxtecan (for stomach and metastatic breast cancer) carry substantial price tags, with MRPs often in lakhs per injection/vial. Despite generating over $100 billion in estimated revenue globally since 2014, less than 1% of eligible patients in India have access to these critical therapies. This stark disparity highlights the urgent need for wider biosimilar adoption.

Biosimilars vs. Generics: Understanding the Difference

It is essential to differentiate biosimilars from traditional generic drugs. While both offer more affordable alternatives, their nature and regulatory pathways differ significantly:

Biosimilars Generics
These are “highly similar” but not identical copies of complex biologic drugs, derived from living cells.

Due to their intricate structures and manufacturing processes, biosimilars require rigorous comparative studies, including clinical trials, to demonstrate no clinically meaningful differences in safety, purity, and potency compared to their reference product.

This makes their development more complex, time-consuming (5-9 years, costing over $100 million), and expensive than generics.

These are chemically identical replicas of small-molecule drugs, manufactured through chemical synthesis.



Their development is less costly and quicker, and they are generally interchangeable with the original drug.

Challenges Impeding Biosimilar Adoption in India

Despite the advantages, several factors contribute to the limited uptake of biosimilars in India:

  • Regulatory Challenges: The existing regulatory framework for biosimilars, though recently updated in draft form (2025 Draft Guidelines), has historically been a significant barrier. Requirements for mandatory animal studies and extensive comparative safety and efficacy trials have made the approval process resource-intensive and time-consuming. While the new draft guidelines aim to streamline the process by allowing for reduced animal testing and making clinical trials optional in certain situations, civil society groups are pushing for further relaxations and clearer definitions to avoid ambiguity and potential delays.
  • Intellectual Property: Patent thickets and strategic litigation by originator companies can delay the market entry of biosimilars, limiting competition and keeping prices high.
  • High Development Costs: The substantial investment required for research, development, and manufacturing of biosimilars, while less than originator biologics, is still considerable, deterring some manufacturers.
  • Lack of Awareness and Acceptance: Misconceptions among healthcare professionals and patients regarding the safety, efficacy, and interchangeability of biosimilars can hinder their prescription and adoption.
  • Infrastructure and Expertise: Developing and manufacturing biosimilars requires specialized infrastructure and a highly skilled workforce, which can be challenging to scale up.

Driving Systemic Change: Civil Society’s Unified Call to Action

The 2025 Draft Guidelines on Similar Biologics by the Central Drugs Standard Control Organisation (CDSCO) are indeed a significant step towards making affordable, life-saving biosimilars available to millions of Indians. As expressed in a recent letter dated July 18, 2025, from civil society members K.M. Gopakumar and Jyotsna Singh, Co-convenors of the Working Group on Access to Medicines and Treatment, these guidelines reflect India’s commitment to ethical science and global standards by following the “3Rs” principle (reduce, refine, replace) in animal testing. However, the letter highlights crucial areas for further improvement to truly unlock the potential of biosimilars in India.

1. Eliminating Unnecessary Animal Studies: While the draft guidelines aim to reduce animal testing, civil society advocates urge for a complete waiver when laboratory tests unequivocally demonstrate a biosimilar’s near-identicality to the original drug. As the letter points out, developed regulatory bodies like UK MHRA, EMA, Health Canada, and USFDA have largely moved away from mandatory animal testing. The discretion currently left to licensing authorities in India risks increasing costs and delaying access to affordable biosimilars. Removing these tests would lower production costs, accelerate development, and uphold ethical standards, directly translating to more affordable medicines for patients.

2. Clarity in Waiving Clinical Efficacy Studies: The provision in the draft guidelines to skip comparative clinical trials when biosimilarity is proven through lab tests is a positive step. However, the current language, stating that a comparative efficacy trial “may not be necessary if sufficient evidence of bio-similarity can be inferred,” lacks explicit definition of “sufficient evidence.” This ambiguity, as highlighted by Gopakumar and Singh, could lead to regulatory arbitrariness and even legal challenges from originator companies.

In contrast, international guidelines, such as those from the UK MHRA and the EMA Reflection Paper, provide clear circumstances for waiving clinical efficacy studies. For instance, the UK MHRA explicitly allows waivers when analytical comparability, in vitro pharmacology, and comparative pharmacokinetic (PK) data are robust. Similarly, the EMA indicates that biosimilars may be approved without comparative efficacy studies (CES) or even pharmacodynamic (PD) data if sufficient evaluation of analytical comparability, in vitro pharmacology, and a comparative clinical PK trial supports it. Civil society strongly urges the CDSCO to explicitly define the situations requiring comparative clinical trials, mirroring the clarity found in these international guidelines.

Call to Action

The 2025 Draft Guidelines on Similar Biologics offer a historic opportunity to advance India’s healthcare system. By incorporating these vital recommendations – fully eliminating unnecessary animal studies, clearly defining conditions for clinical trial waivers, and unequivocally prioritizing affordability – India can make biosimilars more accessible, reduce ethical concerns, and reinforce its global leadership in providing affordable medicine.

The Working Group on Access to Medicines and Treatment, along with other civil society groups, requests the CDSCO to engage with patient groups and healthcare advocates during the finalization of these guidelines and ensure the process remains free from any conflict of interest. This concerted effort will not only enhance access to life-saving treatments for millions but also reinforce India’s commitment to equitable healthcare. The journey “Beyond Monoclonal Antibodies… Gene Therapies” and other advanced biologics hinges on the success of making biosimilars truly affordable and accessible to all.

Resources:

Dr. Preeti Chauhan, Head of National Policy at Pallium India, spearheads policy advocacy efforts to improve palliative care in India. The National Policy division works to enhance access to pain relief and palliative care, promoting policy changes and capacity building to support patients with life-limiting illnesses

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