With the current expirations of drug’s patents, biosimilars are grabbing their place into the therapy industry. Biosimilars market was $1.3 billion in 2013 globally and is expected to reach $35 billion by 2020 with the core reason of the patent expiration of additional ten blockbuster biologic drugs. For now, there are many biosimilars which have been approved by regulatory authorities, and have started serving humanity. Biosimilars approval strictly depends upon thorough demonstration of “comparability” of the “similar” product to an existing approved product. Therefore it is must for biosimilars to undergo both non-clinical and clinical test that the most sensitive clinical models suggest to show differences between the two products in terms of human pharmacokinetics (PK) and pharmacodynamics (PD), efficacy, safety, and immunogenicity. As the competition is increasing everyday on accelerated approvals of biosimilars, patients will surely be having more treatment options, along with medications they need for serious disorders at much lower costs than the original biologics. The FDA’s approval of an accelerated timeline for biosimilars is hugely supporting a change in the industry and profits for pharmaceutical companies. It brings an opportunity for ventures specializing in generics and biosimilars to grow their businesses at nice pace. Regulatory authorities and sponsor companies are on a common agreement that if a biosimilar passes through a comparability exercise indicating its similarity as close to the originator product, then an abbreviated clinical trial plan would be sufficient. In addition, there is very important information as of Dec 2017 that Biosimilars are not allowed to be dispensed in place of another biological product unless a physician or other healthcare professional specifically prescribes the biosimilar product by name; no products are deemed as “interchangeable” by the FDA. Regarding naming of biosimilars; FDA issued a guidance in Jan 2017; according to which the nonproprietary name designation “will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters”.

To know more on biosimilars; be a part of our next event, i.e 13^th Biosimilar Congregation which is going to be held in December 2018, India. Find more details on http://www.virtueinsight.com/upcoming-conferences/