Biosimilars

OVERVIEW

Polpharma Biologics is committed to providing patients worldwide with access to the most advanced life-saving and life-improving therapies available. As biologics continue to advance the treatment of some of the most historically complex conditions, we are leveraging our large molecule capabilities to develop a number of biosimilars – biologic medicines that have no meaningful difference from their reference product in terms of safety and efficacy and are more affordable than the originator drug.

 

At the Forefront of the Industry

A recent report from Clarivate Analytics forecasts approximately $100 billion worth of biologics to lose patent protection in Europe and the US over the next few years*. As demand for biosimilars continues to rise, biopharmaceutical manufacturers with robust cell culture capacity and highly productive cell lines are becoming increasingly essential. Recognizing this need, Polpharma Biologics has made significant investments in our facility and technology infrastructure to enhance our ability to bring these critical therapies to market.

We have a current pipeline of six biosimilar products, including:

  • Two candidates showing high biosimilarity successfully advanced to commercial and currently in clinical stages
  • Two candidates brought to stage of proof of biosimilarity
  • Two candidates in earlier stages of development

Our Process

A typical biosimilar program at Polpharma Biologics begins with the development of more than 40 different analytical methods to deeply characterize the protein of interest and identify its core quality attributes. This process plays a crucial role in achieving biosimilarity of the final product.

Based on the cell production line developed by our proprietary platform in Utrecht, we further optimize both upstream and downstream processes to increase productivity while maintaining all relevant quality attributes. Over many years of experience, we have developed an innate understanding of process development and optimization through a series of multivariate experimental designs following Quality-by-Design (QbD) principles.


From Lab to Market

Polpharma Biologics is one of the few one-stop-shop biopharmaceutical companies with the capacity to conduct large-scale production of biosimilars. All of our development and manufacturing activities are done in-house, which greatly reduces risk and increases efficiency. Technology is transferred seamlessly from process development to clinical manufacture using the same or comparable equipment, and we have the flexibility to make quick, contextual decisions that best support a viable commercial strategy. Following approval, we look to engage highly capable commercialization partners to help market the product.

Polpharma Biologics is one of the few one-stop-shop biopharmaceutical companies with the capacity to conduct large-scale production of biosimilars.

*Source: https://clarivate.com/blog/life-sciences-connect/biosimilars-opportunities-challenges-eu-u-s-russia/

HOW CAN WE HELP?

Whether you are looking to advance a biosimilar program, work on innovative molecules or learn more about our capabilities, we look forward to hearing from you.

Biosimilars

Novel Biologics

Biosimilars

Capabilities

Leveraging our integrated capabilities and world-class facilities, Polpharma Biologics develops and manufactures our own high-quality biosimilars.

Biosimilars

Current Programs

Integrated Capabilities

Find out more about Polpharma Biologics’ end-to-end capabilities, which include CDMO services for drug substance and drug product, as well as the development of our own novel biologics.

CDMO

Polpharma Biologics offers a full range of development and manufacturing services for both biosimilar and innovative programs. Our services are available on a standalone basis or as part of a long-term strategic alliance.

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Novel Biologics 2

As part of our commitment to improving human lives by providing high-quality biologics, we develop next-generation biotherapeutics, including novel antibodies. Starting at discovery, we advance these therapies into clinical studies and look to engage collaborative partners for their full clinical development.

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