Biosimilars: introduction, concerns, and opportunities

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Date: Aug. 2010
From: LC-GC North America(Vol. 28, Issue 8)
Publisher: Intellisphere, LLC
Document Type: Column
Length: 3,649 words
Lexile Measure: 1520L

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Discussion and resolution of the various scientific and regulatory factors behind approval of biosimilars is perhaps one of the most significant events in the last decade for biotechnology. The regulators have the daunting task of maintaining the balance between the financial benefit from allowing approval of biosimilars and the safety of the patients. Now that the U.S. Congress has passed a law allowing biosimilars, we look forward to the timely but responsible creation of a regulatory process that can bring them to the U.S. market.

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The ever-increasing cost of healthcare and improvements in our understanding of the various factors that play a role in the manufacturing of biotech therapeutic drugs have fueled the push for approval of biosimilars (referred to as follow-on protein products in the U.S.). Discussion and resolution of the various scientific and regulatory factors behind the approval of biosimilars is perhaps one of the most significant events in the last decade for biotechnology. Reasons for this are many. For one, biotech processes and products are complex, and while the industry has made significant improvements in our understanding of how the process impacts the product, a lot more must occur. The use of complex feed materials that sometimes have not been fully characterized can further exacerbate this balance. Further, our understanding of how the product quality attributes impact the safety and efficacy of the product in the clinic is incomplete. This can be attributed to the complexities of the human body and is confirmed by the countless examples in the literature of observing significant changes in clinical performance (often undesirable) resulting from otherwise minor changes to the manufacturing procedures. In view of the difficult job that the regulatory agencies have in balancing the financial benefits with public safety, the European Medicinal Agency (EMEA) has done a commendable job at creating the regulatory path to facilitate approval of biosimilars. The U.S. Food and Drug Administration (FDA) is expected to do the same in near future.

In this column, we wish to provide our readers with an introduction to the topic of biosimilars, review the available regulatory guidance, discuss the various scientific challenges that are present, and talk about the opportunity that this provides to the drug manufacturers, regulators and the patients.

What are Biosimilars?

Biosimilars can be defined as biotech drugs that have been shown to have comparable quality, safety, and efficacy to the original product. There are some key differences between the production of biosimilars and that of the traditional small molecule generics:

Different Economics: Cost of manufacturing a biotech product is approximately 5-10 times more than that for a small molecule product. Capital investments as well as operating costs associated with manufacturing of biosimilars are also significantly higher than that for small molecule generics along with the associated risk of failure.

* Data on the launch of biosimilar epoteins in Germany shows that biosimilars represent approximately 35% of the total sales of epoetin (4). This is in comparison to much higher substitution rates than are seen for generic...

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Gale Document Number: GALE|A238476251