Biologics & Biosimilars

We believe high-quality biosimilars that are functionally and physically equivalent to existing biotherapeutics can facilitate access to these lifesaving biological medicines for patients across the globe, while respecting the intellectual property rights of the originator.

Biosimilars are highly similar to the approved reference product, with no clinically meaningful variation in terms of the safety, purity and potency. The biosimilars market is growing and highly fragmented, with no dominant manufacturers.

In the EU, biosimilars have gained broad traction across multiple therapy areas and expanded excess to these important medicines for patients. The United States is a less mature biosimilar market, though in the long run it is expected that policy and regulatory pressures will enable biosimilars to become more widely accepted and utilized.

Public policy statement

Biological products have revolutionized the treatment of patients suffering from some of the most debilitating and life-threatening diseases, and the potential for discovering novel biological therapies remains high. Biological products are complex proteins derived from living sources and are generally more complex than small-molecule drugs, which are usually produced through a chemical process.

Planned spin-off of women’s health, legacy brands and biosimilars into a new company

In February 2020, our company announced its intention to spin-off products from its women’s health, trusted legacy brands and biosimilars businesses into a new, independent, publicly traded company (Organon & Co.).

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, an existing approved reference biological product. Due to the complex development and manufacturing process for biological products, a biosimilar is not required to be “identical” to its reference product, as is the case for small-molecule generics. Instead, a biosimilar is “highly similar” to the reference biological product, notwithstanding minor differences in clinically inactive components. Further, to achieve regulatory approval, there can be no clinically meaningful differences between the biosimilar product and the reference biological product in terms of safety, purity and potency.

The potential for significant savings to national health-care systems clearly exists if high-quality originator and biosimilar biological products can be brought efficiently to the marketplace. This would offer patients, physicians and payers added choices through class competition and affordability, while respecting the intellectual property rights of the originator. We believe that the market for originator and biosimilar medicines should be based on sustainable competition that reflects patients’ safety and health outcomes, access to a variety of medicines, the need for continued investment to discover and develop innovative biological products and savings for health-care systems.

Portfolio and partnerships

Our biosimilars strategy is focused in the short term on investing and expanding our current biosimilar portfolio. In the future, our goal is to expand our offerings and drive future value through partnership.

In 2013, we entered into an agreement with Samsung Bioepis Co., Ltd. to develop and commercialize multiple biosimilar candidates in our partnered territories. Since that time, this partnership has made significant progress on a portfolio that includes biosimilar candidates in immunology and oncology, with a number of biosimilars either already approved or expected to be filed with regulatory authorities in our territories.

We have launched BRENZYS® (etanercept injection), RENFLEXIS® (infliximab-abda) and ONTRUZANT® (trastuzumab) in select markets through 2019. We plan to launch several new products globally, including AYBINTIO® (bevacizumab) and HADLIMA™ (adalimumab-bwwd).

Working in partnership with others, including: