Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance are made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. This term is used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product.
The biosimilars business has developed rapidly those years and thus arousing people attention and interest in this area. Thomson Reuters, the famous news agency based in HongKong recently took a survey about this business and surfaced with a detailed report outlining a bustling new global business with roughly 700 so-called follow-ons put in the clinic by 245 companies and institutions. Analysts of this report say that it is very likely that biosimilars will account for about $25 billion out of $100 billion in sales for off-patent biologics.
The EU was the first to realize the importance of biosimilar business and has laid a regulatory pathway for its development. Drugmakers in India and Korea almost at the same time made plans to deliver less expensive biosimilars to the developing world, where people often find themselves unable to afford biologics at branded prices. And while the U.S. is quite slow in action in this area and is just now opening its door to biosimilars. According to the survey of Thomson Reuters’ BioWorld, dozens of meetings have been opened at the FDA with developers racing to penetrate the world’s biggest drug market.
An Earlier report expected 20% to 30% discount off the price of biosimilars and the result of Thomson Reuters’ report just proved that estimate. Despite that, manufacturers are still very positive about this market. They plan to fight back by offering similar discounts on their aging products. And the lead developers in the space, meanwhile, are working up some ambitious grassroots marketing campaigns aimed directly at physicians and payers as they go toe-to-toe with the originators. And undoubtedly, this battle will soon begin in US.
As more countries start to realize the important role of the biosimilar products, the competition within the area will be more brutal in near future.