Biosimilar Drug Development – The Analytical Strategy is a Key Factor for Your Success

Biosimilar Drug Development – The Analytical Strategy is a Key Factor for Your Success

How to Meet the Challenges of Developing a Biosimilar

The generation of analytical data for the comparison between a biosimilar and the originator product is the initial assumption in the development of biosimilars.

Achieving biosimilarity can be a controversial and complex topic when deciding on the right time point and range of analytics. Protagen Protein Services (PPS), with 20 years of market experience in protein analytics and over 500 customer projects successfully completed, guides you as your pilot and analytical service provider in your efforts, offering a stepwise approach to all aspects of analytical characterization combining structural, physical and functional data in order to provide a meaningful assessment of biosimilarity.

Effectiveness and Economic Efficiency

The efficiency and long-term safety for a biologic are largely based on clinical studies that have already been conducted. Any biosimilar development project aims to develop a product highly similar to the reference biologics. Having an analytical strategy to compare the physicochemical properties of a biosimilar to its reference product can therefore provide important clinical data to indicate that clinical similarity exists in safety and efficiency between the reference product and the biosimilar and streamline the development process. Changes in critical quality attributes (CQA) which can occur during the manufacturing process have to be tightly controlled and constantly balanced against the originator”s fingerprint. For a successful approval of a biosimilar, the worldwide authorities” stringent requirements have to be met. Hence, in terms of effectiveness and economic efficiency, it is advisable to set up and follow a comprehensive analytical strategy approach from an early stage on the way to regulatory approval.

At PPS, a team of more than 100 specialists focusing on analytics is currently cooperating with 25 companies all over the world in the field of biosimilar development. We work on a basis of mutual trust and reliability. Every client is unique, and so are our individual and well-tailored approaches for designing a project set-up that fits your strategy.

Best Possible Understanding of the Originator

Knowing the reference product as thoroughly as possible is essential for the development of a biosimilar, as is a risk-averse approach. Physicochemical and functional biologic characterization are the most important of the development. They are also the most complex challenges, beginning with the characterization of as many of the quality attributes of the originator as possible, and ending with establishing the acceptable range of variation for each attribute that is considered to be critical. For the initial step we can provide the entire supply chain in worldwide originator sourcing, from single source to batch-to-batch, to make the reference product accessible for further analysis. PPS has analyzed over 30 originators in the last year and gained broad experience in analytical methods to characterize originators for further assessments.

The Process Defines the Product

The more thoroughly your approach is designed, the better your understanding of the manufacturing process will be. Applying suitable methods as part of a comprehensive approach from an early stage onwards is the key. In accordance with FDA and EMA guiding principles on how analytical tests should be performed to assess the analytical similarity or comparability between a reference product and a proposed biosimilar, PPS will be your perfect partner in supporting early selection and preliminary qualification steps.

We provide a broad set and combination of orthogonal analytical methods revealing structure-function relationships, delivering in-depth comparability information, and allowing extrapolation towards non-measured attributes to compare the physicochemical and biological characteristics of the two products, in some cases down to the fingerprint level. The method set is able to cover the primary, secondary, and higher order of protein structure; the purity and impurities; and the post-translational modifications, such as glycan profiles. We have the capacities and the long-term experience to accompany complex biosimilar development projects by establishing the quality target product profile (QTPP), by applying forced degradation and using state-of-the-art methods to detect potential differences, and by evaluating molecules and processes according to tailored comparability exercises and regulatory standards.

The Equilibrium of Risks, Costs, and Quality

Developing a biosimilar product is a long-term process lasting years and usually generating considerable costs. So it is especially worth considering risk minimization measures right from the start while maximizing solid results. Fixed budgets give you economic safety during our cooperation. With PPS as your consultant and partner, you will benefit not only from our up-to-date expertise in characterization and testing methods but also from our worldwide network which includes sourcing companies and representatives of regulatory authorities in order to ensure good quality and to meet the valid standards for approval.

Keywords:Biosimilar, Protein, Analysis, Analytics, Charaterization, Drug Development, Biologics, Biopharmaceuticals, Biotherapeutics