A Biosimilars Company in India Serving Globally

Biosimilars Manufacturer in India: An Integrated Partner for Global Biosimilar Programs

Shilpa 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.

What Are Biosimilars and How Do They Differ?

Biosimilars, sometimes searched as bio similars, 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.

Why International Partners Choose a Biosimilars Manufacturer in India

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:

• Global quality standards: Quality systems aligned to WHO-GMP, ICH and PIC/S, with CDSCO revised Schedule M GMP and EU GMP.
• Cost that fits emerging and mid-size sponsors: A biologics-only cost base that makes a regulated-market biosimilar program realistic rather than prohibitive.
• A focused biologics team: Scientists and engineers who work only in biologics, never split across an unrelated portfolio.
• Integrated capability: Development, drug substance, analytical and fill-finish on one campus, which is more than most biosimilar companies in India offer end to end.

How Shilpa Biologicals Manufacture Biosimilars

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.

Advantages of Partnering with Shilpa Biologicals

Choosing Shilpa Biologicals as your biosimilars manufacturer brings a set of practical advantages to a program:

• A single technology transfer: Development, drug substance, analytical and fill-finish sit under one roof, so there is one transfer to manage rather than several.
• Lower program risk: Comparability is where biosimilar programs most often stumble, and keeping analytical work in-house and close to manufacturing reduces the chance of a late surprise.
• Regulated-market readiness: Quality systems aligned to WHO-GMP, ICH and PIC/S, with CDSCO revised Schedule M GMP and EU GMP.
• Cost efficiency: A biologics-only cost base that keeps a biosimilar program viable for emerging and mid-size sponsors.

Our Biosimilar Pipeline Across Three Therapy Areas

Shilpa Biologicals' biosimilar pipeline spans oncology, autoimmune and dermatology. In oncology we are developing programs covering PD-1 checkpoint inhibition, HER2-targeted antibody drug conjugation and CD38, spanning pembrolizumab, nivolumab, trastuzumab emtansine and daratumumab. In autoimmune disease our anti-TNF work covers adalimumab, and in dermatology our work in type 2 inflammation covers dupilumab.

Each molecule has a dedicated page with more detail on its target, therapy area and development focus. Availability of any molecule depends on the relevant patent position in each territory.

Markets We Serve

We work with pharmaceutical and biotechnology partners across North America, Europe, Latin America, Asia Pacific, the Middle East and Africa. Our priority partnership territories are the United States, the European Union, Canada, Brazil and Japan, with active partner conversations across Mexico, Saudi Arabia, Australia, South Africa, China, Malaysia and the Philippines. Availability for any given molecule depends on the relevant patent position in that territory.

Biosimilar Licensing and Partnership with Shilpa Biologicals

Shilpa Biologicals partners across several models: out-licensing, co-development, dossier plus supply and contract manufacturing of partner owned biosimilar programs. The right structure depends on the territory, the stage of the molecule and whether you need drug substance, finished drug product or a complete package from development through supply.

If you are evaluating a biosimilars manufacturer and licensing partner in India, the fastest route to an answer is to tell us the molecule and the markets you are pursuing, and our business development team will respond.