similisbio_wordmark_color_medA New Kind of
Biosimilar Partner


Jump-start your biosimilar program today with pre-qualified analytical methods, detailed reference product characterization, and off-the-shelf assets proven to meet your product quality and productivity requirements

Experience by the Numbers

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Biosimilar Programs

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FDA Approved Products

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Goal
Make Biologics Universally Accessible

Novel Solutions for
Bringing Biosimilars to Market

Traditional biosimilar CDMOs sell services. Similis delivers validated assets with supporting data and expertise to jump-start your biosimilar development efforts.

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Patent
Discovery

We start every program with detailed patent discovery work, finding all valid and relevant patents in the US and EU. We then work with law firms dedicated to intellectual property law in the pharmaceutical industry to ensure we have a comprehensive understanding of the key patents, anticipated timing of biosimilar competition, and freedom to operate as we begin pre-clinical development.

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Analytical
Development


We complete every aspect of analytical development for each program, including reference product sourcing and characterization, definition of a Quality Target Product Profile, identification of Critical Quality Attributes, and development of the full complement of analytical methods needed to characterize and control the biosimilar.

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Cell Line
Development


We screen a range of biosimilar cell lines for each program, including the Selexis SURE CHO-M Cell Line™ technology, to best optimize product quality, titer, and cell line stability. All of our cell lines include single cell cloning and production of a research cell bank.

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Process
Development


We provide end-to-end biosimilar development processes from early upstream development through completion of a commercially viable manufacturing process in under 10 months – a process that delivers high-quality supplies of drug product for non-clinical and clinical studies. We confirm analytical similarity at every step giving you confidence that the program will be clinically successful.

Looking for Full CMC Biosimilar Development?


Similis provides complete solutions for Chemistry, Manufacturing, and Controls, from target selection through drug product delivery.
Wherever you are on the biosimilar development journey, Similis can tailor a partnership to meet your needs.

CMC Biosimilar development

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Reference Product Data


We begin to source reference products immediately after patent discovery is complete, generally within two years of when the product is made commercially available by the license holder.

We collect the analytical data biosimilar companies need for all pre-clinical biosimilar development, including amino acid sequence, post-translational modifications, and product variant profiles. Up to 30 lots of each reference product are procured and tested to establish meaningful ranges for product quality attributes.

Learn More

We believe in a world where exceptional biologics are universally accessible, made possible by harnessing transformational technology and latent data.

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Maximize Value Through
Flexible Partnership Structures


Similis develops analytical methods, biosimilar cell lines, and process knowhow. Because we independently build these packages and own all assets outright, we are open to a wide range of partnership structures. We provide partnership options ranging from a single analytical method to completed pre-clinical assets off-the-shelf to significantly expedite your biosimilar development.

If we don't have the specific assets you need, we can partner with you to develop a biosimilar of your choice, starting from scratch.

Meet Our Team

Our team has supported over 18 biosimilar programs at all stages of development, helping bring 6 products to market.

john-gabrielson

John Gabrielson

SVP, Biosimilars & Head of Business

John is a seasoned executive, company builder, and strategist with over 15 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading CDMO, John is now focused on accelerating biosimilar adoption across the industry.

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Dayn Sommer

Director, BD & Alliance Management

After completing his doctoral work in 2016 at Arizona State University in biochemistry, Dayn joined KBI Biopharma as an analytical scientist supporting CMC service offerings, before switching to BD operations. His current role supports business development efforts, contract development and partnership negotiations.

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Jared Young

Director, Biosimilar Strategy

Jared has over 8 years of experience developing biologics. He has worked on hundreds of biologics programs and over 15 biosimilar programs. Additionally, Jared has written multiple articles and book chapters, including chapters of the book “Biosimilars” about biosimilar development.

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Andrea Adam

Director, Biosimilar Operations

Andrea has 15+ years of program management and operations experience within the biotechnology industry. With broad experience across all aspects of CMC development, her efforts will focus on defining portfolio strategy and driving executional excellence.

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Brad Prater

Director, Product & Process Development

Brad has 20+ years of biologics development experience, spanning development through commercial lifecycle management. He is focused on identifying the critical quality attributes of biosimilars across the portfolio and driving process development to meet those product quality targets.

Frequently Asked Questions

Let's Discuss Your Biosimilar Development Program Today.

Fill out the form below and we will set up a consultation.

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