Hetero Drugs, one of the largest generic pharmaceutical manufacturing companies in India, has now started exploring the biosimilars market and has already launched three products in the last two years.
Hetero Drugs has become the leader in the supply of antiretroviral (ARV) drugs across the global, and now its ventures into biosimilars is gaining the company many successes. “One out of every three patients across the globe is using ARV supplied from Hetero Drugs and it has become one of the largest exporters ARV medicines across the world. As part of our expansion plans, Hetero has ventured into biosimilars two years back and has successfully launched 3 products viz., Darbepoetin Alf-for anaemia and Chronic Kidney Diseases (CKD), Retuximah—(monoclonal antibody) for treating blood cancers and Bevacizumab--for treating rheumatoid arthritis,” informed Ramesh Reddy, marketing manager, International Biologics Business, at Hetero Labs.
Apart from the above three products, the company is also having two products in pipeline, which are still under clinical trial stage and very soon it is also expecting these products will clear the final clinical trial stage and will be launched in the market very soon. “We have two more Monoclonal Antibody (MAB) products in the pipeline which are under various stages of clinical trial. These include adalimumamb and trastuzumab, once these products get cleared the clinical trial state we will launch them in the market,” informed Reddy, while explaining about the company’s new ventures at BioAsia in Hyderabad.
According to Reddy, the company has two more products in the pipeline to be launched in market soon in the next few days and by 2020 it is expecting to launch at least 10 more products on the commercial scale.
Unlike with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes.
Explaining further, Reddy said that biosimilars are similar to vaccines, but in vaccines, the inactive antibodies are extracted from humans to prepare vaccines, while in biosimilars, the inactive disease causing strains can be extracted from any source belonging to mammalians.