17.04

2018
MSLs in the Biosimilars industry
Written by Dr Niamh O’Reilly

 

We have previously reported this year will be big for biosimilars with several therapies on the horizon to challenge some of the biggest biologic brands. 1 The Australian government has put mechanisms in place to increase awareness of and drive uptake of biosimilars. 2 However, government backing and a more affordable price for these therapies does not guarantee their commercial success. Here we discuss how MSLs can contribute to their company’s strategy for maximising uptake of biosimilars.

Communicating biosimilar data

The science behind both reference brands and biosimilars is complex and healthcare professionals (HCPs) may be more comfortable prescribing and dispensing established brands which have more evidence to support their use in a given patient population. Biosimilar clinical studies vary from traditional studies because they typically include analytical data showing how the structure of the biosimilar compares to the reference drug and how that structure influences the therapy’s function. HCPs may not be familiar with terminology such as bioequivalence and extrapolation across indications, which are commonly used to discuss biosimilars. 3

Therefore, a key activity for MSLs is to educate HCPs about biosimilars along with sharing product specific information. This should help HCPs to understand and embrace the importance of analytical data over traditional clinical study data when discussing biosimilar development. 4 MSLs can be vigilant for potential gaps in HCPs’ knowledge and seek to address their concerns with the aim of helping them become more comfortable prescribing biosimilars to their patients.

Supporting the switch

Controversy remains around the safety of multiple switches between reference biologics and biosimilars. HCPs may have concerns about changing a successfully established brand for a particular patient and also be more wary of the potential for adverse reactions among patients receiving biosimilars. It is important for MSLs to become aware of these concerns and the potential medico-legal implications from a HCP perspective. This issue is relevant to both clinicians and pharmacists. In Australia, pharmacists have the authority via ‘a-flagging’ to substitute a biosimilar product at the point of dispensing provided the prescriber has not indicated that brand substitution is not permitted.

HCPs may not be convinced of the evidence around new biosimilars, which can result in them waiting to assess their peers’ experience before prescribing. 5 MSLs could address this reluctance in a number of ways for example, by engaging with key opinion leaders (KOLs) from abroad where biosimilars are more established to provide peer to peer education. MSLs could also assist HCPs to become involved with ‘switching studies’ for biosimilars listed on the PBS to provide the opportunity to capture real-world evidence for the use of biosimilars in a specific patient group.

Embracing patient centricity

 

Patients should also be considered as key stakeholders. When gathering intelligence about the competitor landscape, MSLs should seek information about patient support programs and other benefits that competitor companies offer. They can gain these insights not only from HCPs but by engaging directly with patient support groups and patient advocates. By doing this they can become knowledgeable about patients’ needs and assist in establishing improved, if not similar, services to ensure the biosimilar enters the market with maximum opportunity for commercial success.

CRC’s experienced team can provide strategic and forward-thinking Medical Affairs solutions to provide our clients with biosimilars maximum competitive advantage.

References

  1. O’Reilly N. 2018. Growth of Biosimilars in Australia. Available at: https://crcaustralia.com/media-releases/growth-of-biosimilars-in-australia/
  2. PBS Website. 2017. Biosimilar awareness initiative and biosimilar uptake drivers. Available at: http://www.pbs.gov.au/info/general/biosimilars
  3. Turner M. and Franzen M. 2017. Biosimilars: An Evolving Commercial Model. Available at: https://www.lifescienceleader.com/doc/biosimilars-an-evolving-commercial-model-0001
  4. Welch A. R. 2016. What Biosimilars Need to Succeed in Clinical Practice. Available at: https://www.biosimilardevelopment.com/doc/what-biosimilars-need-to-succeed-in-clinical-practice-0001
  5. Turner M. and Franzen M. 2017. Biosimilars: Differentiating and Surviving the Cost of Entry. Available at: https://www.lifescienceleader.com/doc/biosimilars-differentiating-and-surviving-the-cost-of-entry-0001