The Drive for Best Practice in Biopharmaceutical Manufacturing - Key business considerations when developing biosimilar products virtually. - BioPharm International


The Drive for Best Practice in Biopharmaceutical Manufacturing
Key business considerations when developing biosimilar products virtually.

BioPharm International
Volume 25, Issue 3, pp. 60-64


A biosimilar, by definition, should not differ from the reference product in terms of safety and efficacy criteria. That said, there are many opportunities for product differentiation beyond price. To avoid the danger of price-only competition and ever-eroding margins, the biosimilar under development needs to embody a different set of values.

In many cases, the originator product was developed some years ago with technologies of that time. Current technologies may allow improvements for a biosimilar. For example, with regards to formulation, using today's state of the art excipients could lead to improved product stability or reduce undesired product aspects. When communicating with prescribing physicians, one may find that packaging sizes or dose volumes of the originator product no longer match clinical practice, so a biosimilar can differentiate itself by addressing these issues. Over the past two decades there have also been many improvements realized in the area of medical technologies, so there is potential for biosimilars to take advantage of state of the art delivery devices.

If a thorough differentiation approach is followed, the product can gain its own character. Add a brand to represent this specific character and it becomes a value-adding, branded pharma product rather than representing a same-but-less-expensive generic product. Not only will the prescribing physician better recognize the product, but investors are also likely to be happier in the end.


It is clear that reducing time-to-market is one of the most important criteria in biosimilar development, but under no circumstances should shortcuts be taken. One pillar of success is the credibility that can be built up through solid product development, especially for an unknown startup, such as Finox Biotech.

The first "customer" of a product will be the regulatory authorities because they will judge product adequacy for approval. The previously recommended continuous involvement of such authorities in the development process—from the start when drawing the overall development plan to the end when preparing submission documents—will be the essential for maintaining credibility with agencies. The agreements made and the recommendations given during these interactions should be followed precisely. It is possible to further enhance credibility by going the extra mile or one step beyond agreed goals; typically adding only marginal costs and time to the development program the return is much enhanced product credibility. For example, one may choose slightly smaller acceptance margins than previously agreed, the power for the clinical trial may be higher than widely accepted 80%, or trials can be given to those with the highest academic rigor.

The second group of customers—the prescribing physicians—must also be convinced of the product's credibility. Similarity to the reference product is a prerequisite for a biosimilar and essential for approval, so there is no marketing argument to be made on efficacy or safety. Therefore, one needs to go beyond similarities by adding value and differentiated product characteristics in line with a scientifically sound, comprehensible and credible product-development story.

A common defensive strategy used by originator companies against biosimilars is unfounded suggestions as to the questionable source and background of such products. Company representatives love to poetically provide imagery of a backyard–underground lab where, under suspicious conditions, the biosimilar competitor is produced. The same negative insinuation is used for non-clinical and clinical development. In reality, biosimilars in highly regulated markets are produced using state-of-the-art processes, while satisfying the current, highest quality standards and are justifiably at least as good as originator products. In some aspects, biosimilars may be even better than originator products based on the fact that

they are developed and regulated with current knowledge. Therefore, it is the biosimilar industry's task to deliver this message to the market, a task best done through products that satisfy the toughest standards and thus gain the highest credibility.


Being part of a nascent industry is exciting, but there is a necessity to continuously adapt to a changing environment and to help shape the industry for the good of its players. Finox Biotech has not yet proven its success, but the company aims to do so by applying the recommendations noted herein.

Only by careful target selection with deep consideration over strengths and weaknesses can one bring about an attractive business case. In a virtual set-up, such a business case can only be translated into product success by carefully choosing the right network of partners. Special attention needs to be paid to the creation of overall product understanding and commitment among selected external partners to satisfy the credo that "the process is the product."

Reduced time-to-market and low cost of goods are essential for biosimilar competitiveness, so it is crucial to form a spirit of swift execution and a strong awareness of essential product attributes rather than wasting time on alternative options. Last but not least, to avoid competition on price alone, a biosimilar must exhibit value-adding characteristics to differentiate it from the reference product. If all of these ingredients are mixed together in the most demanding development environment, answering to the highest standards, a credible and attractive product will emerge.

This article is part of a new series on Basic Training for Drug Development and Manufacture, providing business and technical guides for taking drugs from discovery to development. Send ideas and contributions to the editor at

Anjan Selz is CEO and co-founder of Finox Biotech.

Key takeaways

  • Product differentiation is crucial to target selection.
  • Find partners that align with your company's structure and vision.
  • Product development should be supported by constant communication with regulators.

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