Oncology Biosimilars
PD-1 checkpoint inhibitor, HER2-targeted ADC and anti-CD38 programs for oncology partners.
Explore oncology biosimilars
An integrated biosimilars manufacturer working across oncology, autoimmune and dermatology. We take partner programs from cell line through drug substance, fill-finish and licensed supply, at a cost base that works for emerging and mid-size sponsors.
The licences and certificates our biosimilars campus holds for development, manufacture and regulated-market supply.
Shilpa Biologicals is an exclusive biologics company that develops and manufactures biosimilars. We run mammalian and microbial drug substance, analytical characterization and aseptic fill-finish on a single campus, so a partner program does not fragment across vendors.
That integration is what lets us hold global quality standards while keeping cost within reach of emerging and mid-size sponsors.
For sponsors comparing biosimilar companies in India, the difference is not scale. It is a focused biologics team, quality systems built for regulated markets and the flexibility to shape an engagement around your molecule rather than around our capacity.
From cell line to licensed supply, under one roof.
One campus, one quality system, one technology transfer to manage.
PD-1 checkpoint inhibitor, HER2-targeted ADC and anti-CD38 programs for oncology partners.
Explore oncology biosimilarsAnti-TNF programs for rheumatology and immunology partners.
Explore autoimmune biosimilarsType 2 inflammation programs for dermatology partners, led by atopic dermatitis.
Explore dermatology biosimilars| Molecule | Therapy area | Target / MoA | Commercial availability |
|---|---|---|---|
| AdalimumabGlobal | Therapy areaAutoimmune | Target / MoAAnti-TNF-alpha | Commercial availabilityAfter relevant patent expiry |
| Pembrolizumab | Therapy areaOncology | Target / MoAAnti-PD-1 | Commercial availabilityAfter relevant patent expiry |
| Nivolumab | Therapy areaOncology | Target / MoAAnti-PD-1 | Commercial availabilityAfter relevant patent expiry |
| Trastuzumab Emtansine | Therapy areaOncology | Target / MoAHER2-targeted ADC | Commercial availabilityAfter relevant patent expiry |
| Dupilumab | Therapy areaDermatology | Target / MoAAnti-IL-4 receptor alpha | Commercial availabilityAfter relevant patent expiry |
| Daratumumab | Therapy areaOncology | Target / MoAAnti-CD38 | Commercial availabilityAfter relevant patent expiry |
| Aflibercept | Therapy areaOphthalmology | Target / MoAVEGF Antagonist | Commercial availabilityAfter relevant patent expiry |
Biosimilars will be available commercially after relevant patent expiry.
Tell us the molecule and the markets you are pursuing. Our business development team will come back with what is possible on licensing, co-development or contract manufacturing.
Most sponsors evaluating biosimilars manufacturers in India are choosing between scale and attention. We are built for the second. Shilpa Biologicals works only in biologics, so your program is never competing for capacity against an unrelated portfolio.
Development, drug substance, analytical and fill-finish sit on one campus and answer to one quality system. Partners get a team that moves quickly, an engagement model that flexes with the stage of the molecule and a cost base that makes regulated-market supply realistic for emerging and mid-size companies. That combination is why partners shortlist us.
Development, mammalian and microbial drug substance, analytical and fill-finish in one campus.
Cost-efficient programs sized for emerging and mid-size sponsors.
A hybrid, responsive engagement model that adapts to your program stage.
WHO, ICH and PIC/S aligned quality systems built for regulated-market supply.
Share the molecule and the territories you are pursuing. Our business development team will confirm availability for your markets and outline the models open to you.
What sponsors ask before starting a biosimilar program with us. Can’t find your answer?
Talk to our teamShilpa Biologicals is a biologics-only biosimilars manufacturer working across oncology, autoimmune and dermatology. Our pipeline covers monoclonal antibody and antibody drug conjugate programs, including adalimumab, pembrolizumab, nivolumab, trastuzumab emtansine, dupilumab and daratumumab. Biosimilars will be available commercially after relevant patent expiry.
As an integrated biosimilars manufacturer in India, Shilpa Biologicals takes partner programs from cell line through drug substance, analytical characterization and fill-finish on a single campus. That integration holds global quality standards while keeping cost within reach of emerging and mid-size sponsors.
Shilpa Biologicals is recognized among focused biosimilar companies in India for quality systems aligned with WHO-GMP, ICH and PIC/S, with CDSCO revised Schedule M and EU GMP. We work only in biologics, so partner programs are never competing for capacity against an unrelated portfolio.
Yes. Alongside our own pipeline, Shilpa Biologicals provides biosimilar development and manufacturing under contract, covering mammalian and microbial drug substance, analytical characterization and aseptic fill-finish for partner owned programs.
Absolutely. As a biosimilar drug substance manufacturer, Shilpa Biologicals runs both mammalian and microbial production, matched to the reference biologic and supported by in-house analytical and comparability work.
Shilpa Biologicals’ biosimilar pipeline spans oncology, autoimmune and dermatology, from PD-1 and CD38 programs in oncology to anti-TNF in autoimmune disease and type 2 inflammation in dermatology.
From cell line and process development through analytical comparability, drug substance manufacturing and aseptic fill-finish, Shilpa Biologicals manages every stage of biosimilar manufacturing in one place, which removes the handoffs that slow programs down.
Yes. Our quality systems are built for regulated-market supply, aligned to WHO-GMP, ICH and PIC/S, with CDSCO revised Schedule M GMP and EU GMP. This makes Shilpa Biologicals a dependable biosimilars manufacturer for partners targeting the United States, the European Union and other regulated markets.
Share the molecule and territories you are pursuing through the enquiry form on this page. As a biosimilars manufacturer and licensing partner in India, Shilpa Biologicals will confirm availability for your markets and outline the out-licensing, co-development and supply models open to you. Biosimilars will be available commercially after relevant patent expiry.
Serving partners across the Americas, Europe and the Asia-Pacific, with dossiers and batch release supported market by market.
United States
Canada
Austria
Belgium
France
Germany
Italy
Netherlands
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
Australia
Japan
South Korea
Brazil
Russia
IndiaCampus
Indonesia
Malaysia
Philippines
Thailand
Egypt
Israel
Kenya
Nigeria
Saudi Arabia
South Africa
Türkiye
United Arab Emirates
Argentina
Chile
Colombia
MexicoShilpa Biologicals is a biologics-only company and a focused biosimilars manufacturer in India, working with emerging and mid-size pharmaceutical and biotechnology partners worldwide across oncology, autoimmune and dermatology. We take partner programs from cell line through drug substance, analytical characterization and fill-finish, then on into licensed supply, under one quality system. Whether you need full biosimilars development and manufacturing across the lifecycle or a single stage such as drug substance or aseptic fill-finish, Shilpa Biologicals offers a flexible and cost-effective route to regulated-market supply. Biosimilars will be available commercially after relevant patent expiry.
Biosimilars, sometimes searched as bio similar, are biologic medicines developed to be highly similar to a reference biologic that is already approved. Because biologics are grown in living cells rather than made through chemical synthesis, a biosimilar is not an identical copy. It is matched to its reference product through an extensive comparability exercise across structure, function, purity, potency, safety and efficacy, with the goal of showing that no clinically meaningful differences exist. That is the essential difference between biologics and biosimilars. The biologic is the original innovator medicine, and the biosimilar is a later version proven to be highly similar to it. It is also what makes a biosimilar different from a generic. A generic is a chemically identical copy of a conventional medicine, while a biosimilar is a large and complex protein that can be closely matched but never exactly replicated. Shilpa Biologicals works exclusively in biologics and biosimilars.
India has become a serious base for biosimilars development and manufacturing, and partners increasingly choose a biosimilars manufacturer in India for a balance of quality and cost that is hard to find elsewhere. With Shilpa Biologicals, that balance looks like this:
Our biosimilar manufacturing process begins with a thorough characterization of the reference product, because everything downstream is engineered to match it. Cell line and process development then establish how the molecule is expressed and purified, and analytical work runs in parallel to compare the candidate against the reference across every quality attribute that matters. Drug substance is produced in mammalian or microbial systems depending on the molecule, and drug product is formulated and filled on our EU GMP approved fill-finish line, followed by stability testing across the intended shelf life and storage conditions. This is the same integrated route, from the manufacturing of biosimilars through to finished drug product, that partners rely on for consistent quality and a clean technology transfer.
Choosing Shilpa Biologicals as your biosimilars manufacturer brings a set of practical advantages to a program:
Biosimilars follow an abbreviated but rigorous pathway. Regulators including the EMA, the US FDA and CDSCO require a stepwise comparability exercise, beginning with analytical similarity, then functional and non-clinical work, then targeted clinical studies. The evidence must establish that no clinically meaningful differences exist against the reference biologic. Requirements differ by region, which is why the target market should shape the development plan from the start.
Tell us the molecule and the territories you are pursuing using the enquiry form on this page. Our business development team will confirm availability for your markets and outline the partnership models open to you. Biosimilars will be available commercially after relevant patent expiry.
We work across out-licensing, co-development and dossier plus supply arrangements, and we also take on contract manufacturing for partners developing their own biosimilar. The structure is shaped around the territory, the stage of the program and whether you need drug substance, finished drug product or a complete package.
Our pipeline covers oncology, autoimmune and dermatology, including adalimumab, pembrolizumab, nivolumab, trastuzumab emtansine, dupilumab and daratumumab. Availability varies by territory. Our business development team will confirm what is open in your markets.
Yes. Alongside our own pipeline we run contract development and manufacturing for partner biosimilar programs, covering mammalian and microbial drug substance, analytical characterization and aseptic fill-finish on our EU GMP approved fill-finish line.