Did you know that over $200 billion worth of biologic drugs are about to lose their patents by 2030. Which opens a golden pathway for a number of existing or new biosimilar companies to step in with affordable alternatives to these drugs.
India is on a clear advantage in this chase, with strong pharma manufacturing, growing global trust, and government support, biosimilar companies in India are well-placed to grow in this space.
In this reading are going to first have a look at the major reasons of rapid growth biosimilars in India, and the 10 major companies who are raising fast in biosimilar industry.
If you're not looking at biosimilars in 2025, you're missing the next big growth wave.
The market value of biosimilars in India has reached around INR 2.2 billion in 2024 and it is projected to reach around INR 16.6 billion by 2034, that’s an insane 25.2% CAGR of growth.
But what could be the key reasons for this rapid growth? Here’s what we have uncovered:
One of the major reasons for rapid growth of biosimilars in India is the “Make in India” campaign from the government.
Under this policy, regulatory clearances have taken up pace, that gives great momentum to biosimilar companies in India. Additionally, the provision of incentives to companies for domestic manufacturing has also been a great help from the government.
With the expansion of public health programs, demand of affordable biologics and biosimilars is also increasing. This leads to an increase in demand, henceforth, increase in investments. Let’s discuss the expansion of healthcare in more details.
Whether public or private, India’s expenditure on the healthcare sector is on the rise. However, out-of-pocket costs are still high, but with biosimilars, affordable alternatives to biologics are also rising.
This shift not only cut the costs, but also improves access to biologics. Millions of patients, who were out-of-bounds from biologics can now afford biologics.
Multinational pharma companies aren’t ignoring India anymore. They’re teaming up.
An array of MNCs are also now partnering up, which has also led to a rise in FDIs too. In addition to that tech transfer activity is also playing a major role, especially for monoclonal antibodies and next-gen biosimilars.
India’s talented, cost efficient personnel and regulatory maturity attracts biosimilar companies.
|
Reason |
Description |
|
Government Support |
Make in India, faster approvals, subsidies etc. |
|
Healthcare Expenditure |
Increased expenditure on healthcare led to affordable biologics, and patient access |
|
Foreign Partnerships |
Increase FDI, licensing deals, and manufacturing partnerships |
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As we have already discussed how government’s support, expenditure in healthcare sector has led to global partnerships and FDIs.
This has led to entry of global giants and regional specialists to compete in this market and compete for market share. Here are 10 top biosimilar companies in India:
One of the key biosimilar company in the Indian market is Pfizer, which is aggressively scaling their biosimilar access in India.
The key strategy they are following is partnerships with the local companies. Pfizer is using these partnerships to deliver oncology and inflammation biologics at a greater speed.
|
Focus Areas |
Oncology, Immunology, Inflammation |
|
Strategy for India |
Strategic partnerships with local organizations for faster commercialization |
|
Key products |
Bevacizumab, Trastuzumab biosimilars |
Eli Lilly is a renowned biosimilar company is diabetes and cancer care. This biosimilar company is using India market and increasing their scale volumes. This helps them to launch biosimilars through trusted distribution partners.
|
Focus Areas |
Diabetes, oncology |
|
Strategy |
Licensing, co-marketing |
|
Key Products |
Insulin Glargine biosimilar |
Celltrion Healthcare’s strategy is to focus on autoimmunity and cancer. With this model, this biosimilar company gets direct market access, less intermediaries, and overall better control and rapid deployment.
|
Focus Areas |
Autoimmune, Oncology |
|
Strategy |
Direct supply, selective partnerships |
|
Key Products |
Infliximab, Rituximab biosimilars |
Viatris, which was formerly known as Mylan is a deeply rooted biosimilar company in India. Their partnership with Biocon, helps them to co-develop biosimilars. They are a key exporter to global markets.
|
Focus Areas |
Oncology, Endocrinology, Autoimmune |
|
Strategy |
Co-devlopment with Biocon |
|
Key Products |
Trastuzumab, Insulin Aspart |
Through their Sandoz division, Novartis is offering one of the most diversified biosimilar portfolios. India has emerged as a key market for scaling and trial support.
|
Focus Areas |
Oncology, Immunology, Endocrinology |
|
Strategy |
Portfolio launch through Sandoz India |
|
Key Products |
Pegfilgrastim, Epoetin alfa |
One of the fastest growing biosimilar company in India is Samsung Bioepis Their key focus is on co-marketing biosimilars in immunology and ophthalmology. They are doing this majorly through India pharma majors.
|
Focus Areas |
Ophthalmology, Immunology |
|
Strategy |
Distribution via local CROs and CMOs |
|
Key Products |
Ranibizumab, Etanercept |
Stada is a Germany-based biosimilar company, who is targeting niche areas such as nephrology. They are working with domestic-players in India to penetrate underserved therapeutic segments.
|
Focus Areas |
Nephrology, Inflammatory Diseases |
|
Strategy |
Collaborations for specialty biologics |
|
Key Products |
Filgrastim, Adalimumab |
Teva is focused on affordability. In India, this biosimilar company has a sourcing hub for both biosimilar development and contract manufacturing. This is majorly for the early-stage biologics.
|
Focus Areas |
Autoimmune, Oncology, Respiratory |
|
Strategy |
End-to-end development with Indian CDMOs |
|
Key Products |
Rituximab, Trastuzumab |
Intas is an Indian biosimilar company which is a global powerhouse in biosimilars. They exports to Europe and their operations are accordance to the global GMP standards. Their specialty is in monoclonal antibodies.
|
Focus Areas |
Oncology, Autoimmune, Nephrology |
|
Strategy |
Manufacturing and global exports |
|
Key Products |
Filgrastim, Pegfilgrastim, Rituximab |
LG is using India as a gateway for Asia. It focuses on metabolic and oncology biosimilars, often licensing to Indian firms for wider reach.
For LG, India serves as a gateway for other Asian markets. Their focus is on metabolic and oncology biosimilars. Their licensing strategy to Indian firms allows them to enjoy wider reach.
|
Focus Areas |
Metabolic Disorders, Oncology |
|
Strategy |
Licensing to Indian manufacturers |
|
Key Products |
Insulin, Somatropin |
We have discussed about the giants in the biosimilar industry, that are dominating and growing rapidly not just in India but also around the globe. However, there are some underrated key players are often overshadowed by big names, but their innovative efforts could not be ignored.
These underrated biosimilar companies may not be household names, but they are strategically asserting dominance in niche biologics, and manufacturing integration. Here is a salient view to these companies:
Alvotech is one such biosimilar company based off Iceland. One of their key differentiator is the fact that they own the entire development-to-commercialization cycle. This gives them the control over the cost, unmatched speed and flexibility around the globe.
Their focus is complex biologics such as monoclonal antibodies and they work on early regulatory engagement, which enables them to fast-track filings across the US, Europe, and Asia.
|
Focus Area |
Immunology, Dermatology, Gastroenterology |
|
Key Biosimilars |
Adalimumab (Humira), Ustekinumab (Stelara), Denosumab |
|
Major Partnerships |
Teva (US), Fuji Pharma (Japan), Dr. Reddy’s (India) |
|
Major moves in 2025 |
AVT04 (Stelara biosimilar) launched in Europe, Canada |
Since AVT04 is launched in Europe, Alvotech is now moving towards US market. With interchangeable status granted and it’s partnership with Teva, it is ready to win formulary access. In pipeline, it has biosimilars for Prolia/Xgeva, Simponi and Entyvio.
Formycon is a Germany-based biosimilar company that is known for its highly focused approach towards biosimilar development. Their key differentiator is the fact that they pick assets that have high clinical complexity and market longevity, they do not go behind crowded molecules.
Their speciality is in ophthalmology and autoimmune disorders. They particularly target those biologic delivery methods that pose additional IP hurdles.
|
Focus Areas |
Ophthalmology, Immunology, Inflammatory Bowel Disease (IBD) |
|
Key Biosimilars |
Aflibercept (Eylea), Ustekinumab (Stelara), Ranibizumab |
|
Major Partnerships |
Bioeq, Polpharma Biologics, Coherus |
|
Major Moves in 2025 |
EMA-approved FYB203 (Aflibercept); full EU launch underway |
As their flagship product FYB203, this biosimilar company is now preparing for some additional submissions in the US and Asia-Pacific markets.
They focus on the high-regulation markets, where there is low IP noise and the clinical validation is also strong. They are also working on some secret biosimilars which are in early-stage development, although no additional details are provided as of now.
Amgen is a biosimilar company which is esteemed for inventing biologics. They are fast growing biosimilar competitor to other companies.
With existing biologics infrastructure, deep payer relationships, and unmatched regulatory insight, they are one of the major threats to other biosimilar companies, even the legacy companies.
Since, they are not pure-play biosimilar firms, this dual role allows them to play aggressively on pricing, without compromising on the quality or access.
|
Focus Areas |
Oncology, Inflammation, Nephrology, Hematology |
|
Key Biosimilars |
Avastin, Herceptin, Remicade, Enbrel |
|
Major moves in 2025 |
Expanded distribution via CVS, Optum, and PBM alliances |
In 2025, Amgen’s payer network is extended and they are all set to lock biosimilar adoption at scale. Almost a dozen biosimilars have been already launched by them, and now they are directly competing with the innovators they were once rivals with. Very soon we can expect new filings for oncology biosimilars.
From $34.66 billion in 2024, to $150.26 billion by 2033, global biosimilar market is reaching it’s steepest growth curve. This is majorly driven by biologics going off-patent, payer demand, and shifting regulatory dynamics.
In this run, North America is leading with around 41% market share. However countries like India, Brazil, and South Korea are also catching up.
As pricing wars intensify in the US and EU, market access strategies and formulary inclusion will decide the winners. For Indian manufacturers, this decade offers a golden window to scale exports, license-out technology, and co-develop with global players.
Tracking global biosimilar approvals in real time gives manufacturers a competitive edge.
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