BioVoice News March 2017 Issue 10 Volume 1 | Page 32

expert corner

Wave 2 biosimilars to dominate development pipelines and approvals

The evolution of regulatory framework has led to unleashing of another round of biosimilar products that have potential to expand healthcare access besides saving budgets , writes Dr Charu Manaktala
European Medicines Agency ( EMA ) has approved 25 biosimilars and another 3 have received positive opinion from the Committee for Medicinal Products for Human Use ( CHMP ) as of December 2016 . At the same time , the US FDA has approved 4 biosimilars till date via the 351 ( k ) pathway . In addition , a number of biosimilars have been approved in other highly regulated markets of Japan , Canada , Australia and South Korea . For the years to come we expect a steady stream of biosimilar approvals to continue , with wave 2 biosimilars ( for biologics with patent expiries between 2015 and 2020 ) dominating . This is a reflection of the fact that these products have been biopharmaceutical industry ’ s top grossers for the last few years .
While we do see signs of development of 3rd wave biosimilars ( i . e ., for biologicals with patent expiries beyond 2020 ), however , this is at best sparse , and still quite some time away from regulatory approvals . 2017 could see approval of trastuzumab , rituximab and bevacizumab biosimilars in the EU or US .
Evolution of the regulatory framework
The year 2016 marked the 10th anniversary for approval of the 1st biosimilar in the EU . By this time the basic regulatory framework for biosimilars registration has been established fairly well . A number of regulatory guidelines are in place as well as a good amount of experience has been gained on a number of biosimilars ranging from simple proteins to complex monoclonal antibodies . Some of the other highly regulated markets such as Japan , South Korea , Canada , Australia among others have adopted EU biosimilar guidelines to a large degree . In addition to the revision of some of the earlier guidelines , the EMA published guidelines for pharmacovigilance of biologics in 2016 . The US FDA has published a guidance on the labelling of biosimilars in March 2016 .
The naming of biologicals and interchangability of biosimilars continue to be hotly debated topics . The EMA has approved biosimilars under the same non-proprietary
32 BioVoiceNews | March 2017