Monday, February 19, 2018

DG_recent_photo_004Give us a small brief about Biosimilars & Epygen?

Biosimilar is defined as biological drug product that is highly similar to a Innovator or licensed reference biological product there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

Epygen Biotech Pvt Ltd. is an emerging Biotechnology company in the India, headquartered in Dubai Science Park, Dubai, and UAE with offices, labs and manufacturing facilities in Dubai, India and USA. Currently, Epygen is eyeing at manufacturing its first biosimilar drug, Recombinant Streptokinase, which is in its pre-clinical stage and have licensed this new version of the Thrombolytic protein (rSK) technology from CSIR, Government of India. This critical life saving Biosimilar drug will be launched in the country by 2019 to treat cardiovasular patients who suffered from Myocardial Infarctio, commonly known as Heart attack.

Going by the soul of its corporate slogan “Building Future Strand by Strand” Epygen, established in 2006, has been conducting research and manufacturing a wide range of Recombinant Proteins for the Biopharmaceutical space.logo-main-light-retina (1)The Biosimilar Industry is growing, yet it is a very niche market, why so?

Biopharmaceuticals is emerging as one of the hottest segments of the pharmaceutical industry and is expected to reach US$390 billion by 2020 where biosimilars will account for at least 10% of the overall biologics market, if not much more! Currently the biosimilar industry in India has just enterd into a nascent stage, opening up the gates for the country to make a statement in the world biosimilars scene in times to come. Europe and the USA are leading the way resulting in some growing pains for developers of these products. Biosimilar manufacturing is complex, as the drugs are derived from living cells and is protein based. The manufacture of biosimilars in various stages of development is staggering and the stakeholders will assess this new category of medicines with a focus of driving value based health care, and that includes delivering quality of care, effectively managing cost and also achieving intended patient outreach.  Developing and manufacturing biosimilars is challenging in terms of quality, safety, and efficacy to an already licensed reference product as it is difficult to standardize such inherently complex products based on complicated manufacturing processes. Because of its growing capacity, well esFermenter_tablished biopharmaceutical companies are investing in these important medicines.

One very important aspect of the Biosimilar business is that, it certainly is not everyone’s cup of tea. That is why only 10-15 companies in India, truly made a footing into this segment, when several hundred small molecule Pharma companies crowd the floor. While the global biopharmaceutical industry has made significant progress in mastering the complex science behind manufacturing a biosimilar, it still remains a hurdle for Indian companies, who traditionally had been focusing on scales of producing generic drugs, but missed out on the advancements in the industry. No doubt, with a number of Indian companies now jumping into the biosimilar segment, taking special cognizance of the critical technology aspects, the barrier from a technological standpoint has significantly come down. However, it will continue to remain an important consideration for any newcomer trying to enter this segment, who does not have background in fermentation, protein purification and DSP and the associated regulations. In near future, it is critical that these biosimilar aspirants streamline their regulatory compliance in wake of the new stipulations, with respect to the producing and processing of molecules as well as clinical trial data. This will open up the golden gates to a much larger global Biosimilar market, potentially changing the game of Indian biosimilars. Challenge will now evolve beyond developing a biosimilar molecule that is a fingerprint copy of the original, to achieving a Bio-better, more efficient and safer protein for patient with a further improved profile, maintaining all the proofs of biosimilarity, with a key focus on optimization of processes and costs without compromising time to market.

Is bio – science restricted to healthcare only?

As per definition by Biotechnology Industry Organization (BIO) of USA, of which Epygen Group is a corporate member, Biotechnology harnesses cellular and bio molecular processes to develop technologies and products that help improve our lives and the health of our planet. Human race has used the biological processes of microorganisms for more than 6,000 years to make useful products for food and healthcare.

Modern biotechnology provides breakthrough products and technologies to combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, and use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes.

Globally, Epygen group has been involved in a range of Industrial Biotechnology activities, ranging from developing recombinant proteins and manipulating genes to make enzymes sustain harsh conditions for usage in the industry. Some

Courtesy : In Conversation with Mr  Mr. Debayan Ghosh – Co-Founder & President, Epygen Group.