How Disruptive are Biosimilars, Really?

14th August, 2016

Category: Communication & Marketing Strategies

Biologics have gained immense popularity over the past decade; in 2014, four of the top five best selling drugs globally were biologics. Their efficacy has been proven for various diseases across therapy areas including cancer, rheumatoid arthritis and Crohn’s disease. However, given the lengthy research and development phase, sophisticated manufacturing process and stringent handling requirements, biologics are expensive and have been severely restricted in numerous markets in the cost-sensitive MENA region.

Enter biosimilars; categorized by the FDA as:

“A biological product that is approved based on a showing that is is highly similar to an FDA approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.”

However, whilst the FDA has clear statements regarding potential clinical differences between biologics and biosimilars, physicians and payers do not always see it in the same way.

“Interchangeable” is the term most frequently used by key decision making bodies whilst assessing the formulary inclusion processes for a biosimilar. There is little awareness of the fact there there are, in fact, guidelines on interchangeability.

“An interchangeable biological product on the other hand is a biosimilar to an FDA approved reference product that meets additional standards for interchangeability.”

What does this mean?

Whilst guidelines are in place, there is little awareness of the exact FDA definitions. In the cost conscious MENA region, biosimilars are thereby compared to biologics as generics are to small molecules, posing the biologics market to great risk.

What can Big Pharma do to assess these risks?

  • Boost awareness of actual, not stakeholder assumed, guidelines
  • Assess the insurance landscape and prioritise markets with greater affordability and likelihood of lesser out of pocket payments
  • Understand the regulatory easy with which biosimilars gain market access vs. biologics
  • Understand INN prescriptions and the degree to which physicians are bound to prescribe by molecule name

Assessing these parameters will allow interested companies to assess at the scope and threat of biosimilars in markets across the region. The markets deemed most relevant according to the firm’s objectives can be further scrutinized to assess the impact of biosimilars per therapy area.