Key Considerations in Biosimilars Development - Understanding opportunities and challenges across all major phases of development. - BioPharm International


Key Considerations in Biosimilars Development
Understanding opportunities and challenges across all major phases of development.

BioPharm International
Volume 25, Issue 10, pp. 37-39


Although biosimilars are not expected to pose any more risk to patients than innovator drugs, their developers should be prepared for significant postmarketing commitments. A potential hurdle with biosimilar pharmacovigilance is specifically tracking which drug patients receive. This problem already is apparent among the branded EPO class drugs. A patient, for example, may receive three different molecules that read "EPO" from three different manufacturers. Unless hospital staff are instructed to maintain strict records, determining which product was administered is difficult, and tracing adverse events backwards can be impossible.


As with innovator drugs, the commercial success of biosimilars depends on the three main stakeholders of market access: payers, providers, and patients. Although the potential cost savings that biosimilars offer may be attractive to payers, some may be reluctant to steer utilization towards these agents without compelling safety, efficacy, and comparability data. Similarly, prescribers and patients may prefer proven treatments over somewhat less-expensive products that may not have a track record.

To facilitate market access, biosimilar developers should therefore consider providing customer support resources, such as reimbursement hotlines, that are on par with those offered for innovator drugs. This offering could be especially relevant for indications such as oncology, where providers have high expectations regarding customer support. Market access will become even more competitive as biosimilars enter the market because innovator companies are expected to ramp up their own customer support resources to solidify brand loyalty. Biosimilars developers also should engage in the full spectrum of market access planning activities, such as conducting landscape assessments and performing market research with stakeholders, early on in clinical development.


Biosimilars development presents challenges at every level, from selection of a manufacturing platform, to analytical assays demonstrating comparability, to in vivo testing and clinical testing, market access, and postmarketing surveillance. Sponsors can minimize roadblocks while streamlining biosimilar development by frontloading analytical methods that demonstrate comparability with the reference molecule, selecting animal studies judiciously, and preparing to maintain a Phase IV drug registry. Companies that navigate these activities successfully may be rewarded with an expedited regulatory review.

Raymond Donninger is senior program manager; Joe Bower, PhD, is executive director of immunochemistry services; Raymond Kaiser, PhD, is vice-president and global science leader of biotechnology services; Sian Estdale, PhD, is principal scientist of protein chemistry in biotechnology services; and John Carlsen, is vice-president of market access services, all at Covance.


1. Datamonitor, "Pharma. Key Trends 2011–Biosimilar Mrkt. Overview" (Feb. 2011).

2. FDA, Guidance for Industry: Scien. Consid. in Demon. Biosimilarity to a Reference Product (Rockville, MD, Feb. 2012).

3. EMA, Similar Biolog. Medicinal Products Contain. Biotechnoloy-derived Proteins as Active Substance (June 2006).

4. M.S. Wroblewski et al., "Emerging HealthCare Issues: Follow-on Biologic Competition," US FTC, June 11, 2009.

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