Biosimilars are expected to play an increasingly prominent role in healthcare, offering patients and physicians additional therapeutic options.1

A biosimilar is a biologic medicine that is approved based on showing that it is highly similar to an existing approved innovative biological product, known as a reference product. However, unlike generic medicines in which the active ingredients are identical to the reference small–molecule drugs, biosimilars will not be identical to the reference biologics due to several components, including the inherent complexity of biologics and the proprietary details of the reference product. Biosimilars made by different manufacturers will differ from the reference product and from each other, making each biosimilar a unique therapeutic option for patients.1

In recognition of the unique and complex properties of biologics, the United States Congress established a distinct, abbreviated pathway for the approval of biosimilars. This pathway requires additional evidence beyond the requirements for generic drug approval, including additional analytical characterization, as well as non‐clinical and clinical data. Because of the complexities, developing and manufacturing high‐quality biosimilars will require manufacturers to have deep scientific and manufacturing expertise.2

Given the complexity and cost of development and manufacturing, biosimilars are expected to be more affordable therapeutic options but are not expected to generate the same level of cost savings as generics. A biosimilar will cost $100 to $200 million and take eight to ten years to develop. A small–molecule generic will cost $1 to $5 million and take three to five years to develop.3


How do Biosimilars Differ From Non-comparables and Biobetters? 4-6

Occurring in countries that may not be highly regulated, a non-comparable biologic is intended to function like a known biologic medicine, but has not undergone strict quality product development. When analytically tested, it is found to have important differences compared to the intended reference product and may not have supporting comparative safety, efficacy, and immunogenicity data.4,5

Similar to a biosimilar, the term “biobetter” refers to a biological medicine which is similar to a product which has already been approved. However, unlike a biosimilar, a biobetter will be an improved version, or superior, to the already-approved product in at least one product characteristic.4,6

References:

  1. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Medicine. 2014;3:889-899.
  2. US Department of Health and Human Services. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf. Accessed November 23, 2016.
  3. US Federal Trade Commission. Emerging health care issues: follow-on biologic drug competition. https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf. Accessed November 23, 2016.
  4. De Mora F. Biosimilar: what it is not. Br J Clin Pharmacol. 2015;80:949-956.
  5. Mysler E, Pineda C, Horiuchi T, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36:613-625.
  6. Conner J, Wuchterl D, Lopez M, et al. The biomanufacturing of biotechnology products. In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Waltham, MA: Academic Press; 2014:351-385.