Monthly Newsletter

Biologic Therapeutics have revolutionised the treatment of many diseases and biosimilars are having a similar therapeutic efficacy with potentially lower costs to the health care system.

The approval of the first biosimilar in the US is expected to save the healthcare industry and patients $5.7 billion over the next decade. However, it is a complex landscape with complexity of manufacturing biologics making the development of biosimilars more challenging than the development of generics.

In addition to this, the upcoming patent cliffs facing manufacturers of blockbuster biologics are daunting – with over $60bn in branded biologic sales coming off patent in the next several years.

The biosimilars and biobetters industry is likely to become a lot more dynamic and strategic than we’ve seen with small molecule generics; there will begin to become a premium on flexibility and willingness to take chances in an ever-shifting competitive and regulatory environment. 

 

The US biosimilars market is expected to reach $1,954 million by 2018 and with the first biosimilar approved recently in America, this is an exciting time for the biosimilar field with approval in the US expected to increase during the next ten years. The regulatory landscape is evolving rapidly so it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between the US and Europe.

The learning objectives in the US should be to fully understand the product lifecycle and all aspects of biosimilar research and development.

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