biochemicalBiosimilar Market Space and Challenges

Biotherapeutics have grown to be an indispensable tool in medicine today. Advances in the development of biologics have offered lifesaving treatments to patients with deadly diseases and quality of life improvements by managing chronic diseases. It sounds too good to be true, so what is the downside?  Biologics are often associated with high costs and limited patient access. This is where the market opportunities open for biosimilars. To date, there are 26 biosimilars approved by the Food and Drug Administration and 53 approved by the European Medicines Agency, with thousands in development. Biosimilars can offer competition in the market to create pricing pressure and expand patient access to innovative medicines.

A biosimilar is a biologic that is highly similar to the approved reference biologic on the market. The FDA defines a biosimilar as “a biological product that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.” However, it’s not as simple as it sounds. The challenge lies in the fact that a biologic is produced in living cells and, consequently, it is a highly complex heterogeneous mixture of products with slight variations. For this reason, it is very important to identify a robust, controlled process and then follow that manufacturing process every time to control natural process variability in biologics.

To demonstrate biosimilarity, a manufacturer must provide sufficient data and information to regulatory agencies to prove there are no clinically meaningful differences from the reference product. The necessary overlap between a biosimilar and reference product is the amino acid sequence and the drug’s mechanism of action. The biosimilar host cell line, processes, and formulation typically diverge from the reference product. Analytical tools must be used to design quality controls to ensure biosimilarity.

For biosimilar approval, regulatory bodies require detailed therapeutic protein characterization including:

  • Batch-to-batch comparisons
  • Stability studies
  • Impurity profiling including aggregation, post-translational modifications, glycoprofiling
  • Determination of related proteins and excipients

The Key to Success- Biosimilar Analytical Strategy

key-hole

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Analytical strategy is key for creating and generating data showing comparability of a biosimilar. This analytical strategy can provide important clinical similarity data streamlining and speeding up the development process. Fully understanding the effects of the manufacturing process on the product at early stages of development allows for generation of suitable methods for product monitoring in later stages. Currently developing a biosimilar is a multi-year process generating considerable development costs, with each biosimilar costing $150-$200 million to develop. Early process understanding can help better define risks and allow for better risk management strategies. For the success of biosimilars, it is important for this process to quickly identify successes and where changes are needed in the process.

Identifying analytical methodologies providing characterization and comparability data in a shorter time can reduce the overall product development and development costs. High-resolution accurate mass  (HRAM) mass spectrometry techniques can bring fast answers during biosimilar development and allow for stringent process control throughout development and into manufacturing. Learn more in this recent application note using mass spectrometry to quickly compare biosimilars to reference products on an intact protein level.

Comparing biosimilars using intact mass analysis under denaturing and native conditions

To learn more, visit: Biosimilar Analysis Workflows