Seven out of the 10 best selling drugs in 2015 were biologics. Yet, as the number of biologic medicines going off patent increases, biosimilar developers will have a tremendous opportunity to capture a greater share of the pharmaceutical market.

Because biosimilars offer a relatively inexpensive alternative, they are expected to reduce the overall cost of medicines by around $108 billion over the next decade in the US alone, resulting in greater patient access. At the same time, it is anticipated that global biosimilar sales will grow at a compound annual rate approaching 50 percent. By 2020, forecasted global sales are expected to reach $26.5 billion.

While the biosimilar market presents many opportunities, sponsors must be aware of several challenges when it comes to developing suitable and effective alternatives to biologics.

1. Knowledge and understanding of biosimilars is limited

To drive adoption of biosimilars, multiple stakeholders (e.g., payers, physicians, and patients) will need to be educated on the benefits of these drugs, as they are relatively new to certain markets. Sponsors must be able to show that, compared to the licensed reference biologic product, biosimilars produce no meaningful clinical difference in quality, safety, or efficacy. 

2. Regulations for biosimilars will vary geographically

The EU has approved twenty biosimilars, but only two have passed the US FDA’s standards. This difference reflects the variations in regulatory procedures from country to country. Therefore, sponsors must be cognisant of each region’s unique policies when creating a drug development programme for global acceptance and approval

3. Pricing strategies will need to reflect payer considerations

To generate interest in biosimilars, sponsors will need to optimise perceptions of value and alleviate any potential concerns about these novel products. As payers play a significant role in determining market access, drug developers must prepare engagement strategies that resonate with their unique interests.