Saturday, January 30, 2016

Saturday, January 2, 2016

Monoclonal Antibodies in India

mAbs in India


Biocon was the first Indian company to come up with its mAbs product, BIOMAb-EGFR (Nimotuzumab). The product was granted regulatory marketing and manufacturing approval in India in September 2006. The product is a therapeutic monoclonal antibody-based drug for treating solid tumors of epithelial origin, such as head and neck cancers.



 “In 2007, Dr Reddy's Labs came out with the novel concept of producing the biosimilar version of Rituximab, a version of Roche's cancer therapy, which could allow a greater access to the drug at half the price of the original. Reditux is the second product from Dr Reddy's Biologics Division, which is developing treatments for cancer and autoimmune diseases. The company has also launched the generic version of Amgen's Neupogen, and named it Grafeel.

Pune-based Serum Institute has entered into another agreement with Akorn of the US in 2007  for definitive development and exclusive distribution rights for rabies mAb.

Intas Biopharmaceuticals has signed a Memorandum of Understanding (MoU) with Government of Gujarat in 2009 for setting up a separate manufacturing facility for MAbs, a recombinant mammalian platform product. The company will invest Rs 160 crore towards setting up a manufacturing facility at Sanand near Ahmedabad. The facility, fully-dedicated for mAbs, will undertake large-scale manufacturing of the recombinant product with a capacity of 5000L in phases.

 Daftary group promoted Bharat Serums and Vaccines and Bangalore-based Avesthagen are some of the other notable companies that have chalked our serious plans for mABs.



“MAbs business involves patents and for navigating through these patents requires skills,”

Future prospects
By 2015 ,  the sales of mAbs is expected to reach Rs 3 lakh crore ($67.6 bn), with a CAGR of 13.8 percent between 2008 and 2015. The biotherapeutic market would be dominated with mAbs in next five years as most of the blockbuster molecules are going off-patented.

All the pharma majors have mAbs projects in their R&D portfolio. Introduction of newer monoclonal antibodies will greatly expand the market. Globally, the FDA had approved four new mAbs and EMA had approved seven new mAbs in 2009. There were at least six new mAbs under regulatory review, 26 mAbs (32 in 2008) are in phase III and over 100 are in phase II clinical trials. There are more than 150 mAbs molecule awaiting regulatory approval. I



Compared to India, China is a big market for mAbs. Some notable  companies include Union Stem Cell and Gene Engineering and Biotech pharmaceutical. In a serious effort towards innovation,China is moving towards areas like stem cells, mAbs, cancer and HIV development and vaccines with investments being pumped in both by the Government and foreign sources.

http://www.biospectrumindia.com/biospecindia/news/157328/monoclonal-antibodies-a-profitable-segment