Indian biosimilar developers seek success in global market
In the next decade, many blockbuster biologics are slated to lose their patent exclusivity, opening the market to a new era of biosimilars that offer the potential to reduce drug costs and increase patient access to lifesaving therapies. However, launching biosimilars is not a one-size-fits-all approach. Each regional market comes with its own unique obstacles and advantages for launching biosimilars; as such, it is critical for biosimilar developers to acquaint their teams with the climate of their regional market as well as any other target markets.
Over the last 25 years, India has established itself as a major player in biosimilar development. The Indian biosimilar market, which was valued at $349 million in 2022, is flourishing; reports anticipate a compound annual growth rate of 25.2% by 2030 (1). Amid this surge, many Indian biosimilar companies may consider launching into European or US markets, which offer increased revenue opportunities due to higher drug prices. Thanks to India’s low domestic manufacturing costs, this can ultimately provide lower price points to US and European patients while also increasing affordable access to patients in other countries.
Establishing a presence in new global markets is an inherently challenging task in the biopharma industry due to regulatory nuances from country to country, but Indian drug manufacturers need only leverage strategy, expert support, and technological innovation to find success. With these tools, Indian biosimilars will increase their presence in global markets and help to satisfy unmet patient needs around the world.
Behind the scenes: the landscape of biosimilars in India
India, which is sometimes referred to as the “pharmacy to the world”, has long been a major global supplier of generic medicines (2). Therefore, it is only natural that India’s drug manufacturers would look to the growing biosimilar market with not only familiarity but opportunity. Though the European Union (EU) was the first pharmaceutical market to release a regulatory framework for biosimilar approval, followed by the US, India approved its first biosimilar, a treatment for hepatitis B, for patient use in 2000—leveraging a traditional biologic approval framework—long before the US and Europe (3).
Since then, the Indian biosimilar market has continued to grow, with over 100 companies engaged in biosimilar development and others continuing to emerge (1,3).Today, more than 100 biosimilars have been approved in India, including vaccines, monoclonal antibodies, and recombinant proteins (1), with a number of key pharmaceutical players in India leading the charge, including Biocon, Intas Pharmaceuticals, Dr. Reddy’s Laboratories, Reliance Life Sciences, Lupin Limited, Zydus Lifesciences, and more (4,5). Biosimilars now make up a significant portion of the Indian pharmaceutical market, and the country’s large population has benefited from the accessibility and lower prices of biosimilars (4).
To reach the country’s market, biosimilars must undergo evaluation by the Indian regulatory body, the Central Drugs Standard Control Organization (CDSCO). Companies first submit applications to CDSCO with thorough data to demonstrate their biosimilar’s similarity to the reference product, and CDSCO then conducts assessments to ensure compliance with safety, efficacy, and quality standards prior to granting approval (4).
To better support companies through biosimilar development, CDSCO collaborated with the Department of Biotechnology (DBT) to write the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India in 2012 (6), revising them in 2016 (3). These guidelines cover manufacturing expectations; quality, safety, and efficacy standards for biosimilars; and pre- and post-marketing requirements (4). As India continues to establish itself as a major global pharmaceutical player, CDSCO has strived to align their guidelines with that of the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) (3). With an abundance of biosimilar uptake in the Indian market, Indian biosimilar manufacturers are now seeking to further establish a stake in heavily regulated markets such as the US and EU, a goal that comes with a number of important considerations for companies as they prepare their development and manufacturing strategies.
How to launch in the US and Europe: What the biggest challenges?
One of the most significant challenges to breaking into the highly regulated biosimilar market is ensuring compliance with stringent manufacturing protocols and training a skilled labor force to execute them. Biologics entail complex manufacturing processes, and biosimilar developers are expected to abide by strict similarity requirements to obtain approval in the US and Europe. As a result, biosimilar companies must enlist state-of-the-art manufacturing protocols and analytical technologies to bolster their regulatory submissions. In previous attempts to break into new markets, missteps by certain Indian manufacturers have led to pushback from global regulatory bodies (7).
In 2017, one firm received three Form 483s from the FDA and one non-compliance statement from the French National Agency for Medicines and Health Products (ANSM), due to practices at its Bangalore plant (7). The violations ultimately delayed the ability to launch the biosimilar in the US and Europe (7). Manufacturing quality concerns can not only result in rejection or delayed approval in new markets, but they can also lead to reduced uptake and acceptance from patients, physicians, and insurance companies if and when a biosimilar is approved.
In addition to manufacturing challenges, there is also a somewhat negative perception surrounding CDSCO’s approach to biosimilar regulation; unlike the US, CDSCO’s guidelines around biosimilar development may not be enforceable laws, which leaves room for interpretation and creates potential safety liabilities (8). Because of what has been perceived as an ambiguous regulatory environment, a number of legal challenges have arisen for Indian biosimilars, including Roche’s legal challenges with several Indian pharma companies (8). To gain approval of their biosimilar in a US or European market, Indian biosimilar companies should continue to pursue alignment with all relevant regulatory mandates. CDSCO should also develop well-defined and enforceable laws for biosimilar manufacturing and approval to help improve harmonization and alignment with established markets and to support domestic companies (8).
As India demonstrates enormous potential as a producer of biosimilars, Indian biosimilar companies can leverage state-of-the-art, GMP approaches to achieve compliance with non-domestic regulatory bodies. With capital investment and intricate knowledge of the global regulatory arena, this is highly doable.
Reach a global market by planning smarter, not harder
Though there are certainly roadblocks to overcome, Indian biosimilar companies have already forged this path successfully. In 2009, Biocon opted to form a partnership with Mylan (now Viatris) to help them break into highly regulated markets like the US and Europe; as a result of this partnership, Biocon was able to benefit from Mylan’s commercialization and regulatory expertise as they aimed to align their biosimilar development approach with FDA and EMA requirements (7). Despite previous manufacturing obstacles in 2017, Biocon resubmitted their application for a trastuzumab biosimilar in November 2017, gaining approval for the drug known commercially as Ogivri 1 year later (7).
To help improve their approach to biosimilar development, Indian biosimilar companies should prioritize compliance and innovation. By committing to GMP manufacturing protocols and quality standards, they can maintain compliance with FDA, EMA, and International Council for Harmonization (ICH) standards and avoid the delays associated with regulatory warning letters. Opting to work with a contract development and manufacturing organization (CDMO) that has experience with biologic development and regulatory expectations in the US and Europe can offer significant benefits, and this is one option to supplement in-house development efforts. A knowledgeable partner will help your team establish compliance and navigate the manufacturing challenges inherent to biologic production, including supply chain limitations, procurement challenges, and the pressure to be first to market.
Finally, Indian drug companies should leverage modern analytical techniques to manufacture a high-quality biosimilar and build a robust data package to share with regulators; said techniques include mass spectrometry, chromatography, and high-resolution imaging for protein identification and characterization (1). Thorough, high-quality data can help drug companies verify that a biosimilar is on track to becoming a safe and efficacious product for patients, and help bolster its potential for approval.
Looking ahead: What are the keys to biosimilar success?
For Indian biosimilar developers, the future is filled with exciting possibilities. The keys to designing a strategic path forward are planning ahead, playing to your strengths, and partnering with vendors that offer experiential knowledge on how to break into competitive regulatory markets like the US and Europe. With a thoughtful approach to biosimilar development, Indian developers will equip themselves with the capabilities and expertise needed to provide more affordable access to lifesaving therapies to patients around the world, establishing India as a leading biosimilar manufacturer.
References
- S. S.. Cementing India’s place as global leader in biosimilars. BioSpectrum India. https://www.biospectrumindia.com/views/17/24948/cementing-indias-place-as-global-leader-in-biosimilars.html. Published July 31, 2024. Accessed January 14, 2026.
- Califf RM. India’s unique opportunity and important responsibility as the pharmacy to the world. US Food and Drug Administration. https://www.fda.gov/news-events/fda-voices/indias-unique-opportunity-and-important-responsibility-pharmacy-world. Published October 25, 2023. Accessed January 14, 2026.
- Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; Current status and future perspectives. J Pharm Bioallied Sci. 2019;11(1):12-15. doi:10.4103/jpbs.JPBS_167_18.
- Priya A. Exploring the growth and impact of biosimilars in India’s pharmaceutical market. Invimeds Health.
- Raju A. Why India must turn biosimilar powerhouse by 2030. BioSpectrum India. https://www.biospectrumindia.com/features/73/24947/why-india-must-turn-biosimilar-powerhouse-by-2030.html. Published July 31, 2024. Accessed January 14, 2026.
- Guidelines on similar biologics: regulatory requirements for marketing authorization in India, 2016. Central Drugs Standard Control Organization (CDSCO) and Department of Biotechnology (DBT). August 15, 2016. https://ibkp.dbtindia.gov.in/DBT_Content_Test/CMS/Guidelines/20181115140059519_Guidelines-on-Similar-Biologics-2016.pdf. Accessed January 12, 2026.
- Woo E, Briggs A, Cheng G.. India, the generic manufacturing powerhouse, biosimilar nNext? Parexel. https://www.parexel.com/insights/article/india-the-generic-manufacturing-powerhouse-biosimilar-next. Published July 21, 2021. Accessed January 14, 2026.
- Vadehra S, Arora A. Biosimilars in India: regulatory, legal, and industry landscape. Lexology. https://www.lexology.com/library/detail.aspx?g=92f2db3f-18c2-4ac7-934e-3f95281ad941. Published September 18, 2024. Accessed January 14, 2026.