Biologics and Biosimilars

Biologics and Biosimilars

We focus on building our biologics capabilities and pipeline and delivering high-quality biosimilar products to help meet the growing needs of patients and health care systems worldwide.



Biologics 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.

In addition to our robust and expanding pipeline of originator biological products to address unmet medical needs, we believe high-quality biosimilars can facilitate access to these lifesaving biological medicines for patients across the globe, while respecting the intellectual property rights of the originator.


We are developing a diversified portfolio of innovative biologic candidates targeting several important clinical indications, including oncology (building on our knowledge of immune evasion by cancer), infectious diseases and cardiovascular disease.

In February 2015, we entered into a broad strategic collaboration with NGM Biopharmaceuticals, Inc., to discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. The collaboration includes multiple therapeutic candidates currently in preclinical development at NGM, including one being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis (NASH).

In September 2014, we entered into an exclusive worldwide licensing agreement (through respective subsidiaries) with Sun Pharmaceuticals Industries, Ltd., for licensing out tildrakizumab, our investigational therapeutic antibody candidate currently in late-stage clinical trials for the treatment of chronic plaque psoriasis.

In 2013, we entered into an agreement with Samsung Bioepis Co., Ltd., to develop and commercialize multiple biosimilar candidates in our partnered territories. Since 2013, this partnership has made significant progress on a portfolio that includes biosimilar candidates in immunology, oncology and diabetes, with six late-stage biosimilar candidates expected to be filed with regulatory authorities in our territories. Through April 2017, RENFLEXIS (infliximab) has been approved in Australia, Korea and the United States; BRENZYS (etanercept) has been approved in Australia, Canada and Korea; and LUSDUNA (insulin glargine) has been approved in the European Union.


Our advocacy position on biologics and biosimilars is built upon a foundational objective of seeking to improve health outcomes while maintaining patient safety. All of our policies associated with biologics, biosimilars or any other drug regulation are motivated first and foremost by our focus on the patient.

Our advocacy recognizes the complexity of all biologic products, both innovator biologics and biosimilars, and seeks to establish sound policy parameters for the development and use of biologics to ensure that patients have access to high-quality, safe and effective medicines. Our policies regarding biologics and biosimilars are based on science, and reflect a balanced approach consistent with our status as a developer of both biosimilars and originator biologics.

For more information, please refer to our public policy statement on Biosimilars and Originator Biologics.