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23 Jan 2015

Intas’s Growth Driver : Biopharmaceuticals

Case Background: Intas’s successful and well recognized product basket also extends to its fully integrated Biotech Business. Intas-Biotech has well established domestic presence in Oncology & critical care with a basket of recombinant DNA technology based products.

Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing and marketing company headquartered in India.

Intas’s success and incessant growth lies in effective execution of its strategic planning in the field of manufacturing, Research & Development, Biotechnology and Global Operations over the last three decades. Today, Intas is more than $650 million organization with CAGR- 30% over the last 5 years and is ranked as the 12th largest pharmaceutical company in the domestic market. [As per IMS Health India, Secondary Stockist Audit (SSA), February 2013]

Diversification is one of the key for sustainability – Intas explored the Biopharmaceutical market 

The Biologics Business Unit (BU) of Intas Pharmaceuticals Limited was formerly an independent biotechnology company and was known as Intas Biopharmaceuticals Ltd. 

Intas-Biotech is focused on production of high quality recombinant therapeutic proteins with fully backward integrated operations. Intas is the first Indian biopharmaceutical company to receive European Union-Good Manufacturing Practice (EU-GMP) certification for its manufacturing facility.

The Biotech business has expertise in product development using various platforms including CHO based, E. coli based, Pegylation etc. The wide range of biotech products including growth factors, interferons, hormones, Monoclonal antibodies and plasma factors highlights its product development capabilities.

The company has state-of-the-art R&D division, cGMP-compliant multi-product manufacturing facility (for bulk as well as finished products) and multi-disciplinary team of scientists with expertise in transforming bench technology to commercial scale in shortest possible time.

Intas Biopharmaceutical Portfolio

The company has successfully launched five therapeutic recombinant proteins including Neukine® (rHu G-CSF), Erykine & Epofit (rHu EPO), Intalfa (rHu IFN Alfa-2b), Neupeg™ (Pegylated rHu G-CSF), world’s first Peg Filgrastim after the innovator and Terifrac (Parathyroid hormone). In addition to these products, there are more than 15 other recombinant molecules in the pipeline at various stages of development. The products developed at Intas Biotech are registered in more than 28 countries throughout the globe.

Intas Biologics has an extensive product portfolio of biosimilars across microbial and mammalian cell culture. Its products include Neukine® (GCSF), Erykine® (EPO), Intalfa® (IFN), Pegasta® (Peg GCSF), Terifrac® (Teriparatide), Mabtas® (Rituximab), Folisurge® (FSH). It is India’s first biosimilars manufacturing unit to receive European Union – Good Manufacturing Practice (EU-GMP) certification for the Drug Substance (microbial) and Drug Product manufacturing facilities, attesting to highest quality of manufacturing and quality systems. In addition to the EU-GMP, Intas’ Biological BU facilities are approved by various other regulatory agencies such as ANVISA, GCC, MCC, Indonesia, etc.

Intas’s collaboration model in exploring biotech business

Intas-Biotech is focused on continuous development & enhancement of research pipeline to meet the increasing market demand. Leveraging its exceptional scientific talent pool and developmental capabilities, Intas is geared up to increase its presence in key thrust areas such as nephrology, rheumatology, oncology and plasma derived products.​

Intas has several strategic marketing alliances and out-licensing collaborations with many International companies across both Regulated and Emerging pharmaceutical markets, such as Europe, China, S E Asia, Middle East, Russia & CIS, South & Central America and Africa.

Intas’ biosimilar are registered in more than 22 countries, and under registration in more than 25 countries, through strategic marketing alliances.

Three of Intas’ biosimilar assets are already partnered for the EU, US, Canada, China and other markets. The first product for the regulated markets will be GCSF and has received EU registration. Several other biosimilar programs are at advance stage of development, and available for partnering discussions.

Intas signed an agreement with Canadian drug major Apotex Inc, in May 2008, to co-develop and market the low-cost version of a biotech cancer medicine filgrastim (G-CSF) in North America and Europe. Intas developed and manufactured Filgrastim (GCSF) became the first biosimilar manufactured by an Indian company to be registered in EU.

Apotex and Intas in Jan 2009 extended their agreement to develop a biosimilar version of pegfilgrastim. This collaboration gives Apotex the rights to market the product manufactured by Intas Biopharmaceuticals in North America, Europe and selected other countries.

Accord Healthcare, the international arm of Intas Pharmaceuticals Ltd, has received marketing authorization for its filgrastim (Brand name Accofil) valid throughout the European Union. The product is manufactured by Intas in its EMA certified plant in India.

Ref:

  • “Intas mfg unit gets EU-GMP certification”. The Economic Times. 13 June 2007.
  • “Intas, Apotex to develop cancer drug”. Business Standard. May 2008.
  • “Apotex and Intas Biopharmaceuticals extend their collaborative development of biosimilars to include Peg filgrastim”. Press Release Intas Biopharmaceuticals. Jan 2009.
  • “Intas Pharmaceuticals Limited – Gets the 1st Biosimilar Approval for EU”. Press Release Intas Pharmaceuticals. Jun 2014.

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