BIOSIMILARS – TAKING THE BIOPHARMA INDUSTRY BY STORM


It was the mid-1990s, when pharmaceutical companies began developing their own versions of medical products. It was unregulated and unheard of at the time, but a steadily growing trend. Comprehensive guidelines were only laid down between 2005 – 2006 by the EU. Not long after, the WHO followed suit and finalised a more consistent set of guidelines for Biosimilars Manufacturing. And thus, began the mainstream prevalence of Biosimilars around the world.


Biosimilars are basically ‘approved’ replicas of innovator biologic products, made by different companies. Biologic medical products are mostly made via DNA recombination technology and comprise of highly complex molecular structures as opposed to normal generic drugs. Normally, they are responsive and highly sensitive to changes in the manufacturing environment. Therefore, the Biopharmaceutical product development process must be able to fully replicate the properties of the innovator product, in order to be available in the market. That’s where WHO’s guidelines come into the picture. They have mandated clinical and non-clinical studies that need to be done in comparison with the original product.

While the Biosimilars Manufacturing process is complex & time consuming, the trend is steadily growing. The industry is predicted to be worth 23.63 Billion USD by 2023, with Europe accounting for the largest market share. Recombinant glycosylated proteins will hold precedence over non-glycosylated proteins, owing to broader therapeutic capabilities.

Furthermore, the Biosimilars Manufacturing market is further segmented under in-house and contract manufacturing projects. While the former has a larger stake at the moment, with a higher incidence of chronic disorders, the demand for Biosimilar is likely to shoot up, keeping both sectors rather busy.

Why are Biosimilars becoming increasingly important?

Predominantly two reasons. They are way cheaper than the original product, making them accessible to a wider audience. Although the biopharmaceutical product development of biosimilars requires heavy investments in terms of time and money, experts believe that they will enable more cost savings than innovator products in the future. Therefore, Biosimilars seem to be boon to the industry as a whole.

In fact, they already have the ‘interchangeability card’ under their belt. With proper medical discretion, patients can opt to switch to a biosimilar product in case they are looking at cheaper options. Hence, they are already en route to becoming strong contenders to original biologics.

Secondly, they are poised to fully replace original innovator products upon patent expiry. According to an article by BioProcess International, 12 products that hold 40% of the current biopharmaceutical market are to face patent expiration by 2020. Therefore, the race to capture this market has already begun.

What kind of diseases can biosimilars treat?    
  
Well since they are in the race with existing biologic products, they can be used to treat chronic illnesses like Cancer, Rheumatoid Arthritis, Cardiovascular Diseases, Diabetes, Inflammatory Bowel disease and Haematological diseases.

Would you like to join the Biosimilars industry? Join the race with Kemwell Biopharma.
 To know more, visit: http://www.kemwellbiopharma.com

Location: Bangalore Rural, Karnataka 562123, India

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