The field of biosimilars continues to grow as more companies invest in biosimilars, and as the FDA continues to clarify the regulatory processes that must be followed to have products approved and marketed in the United States. Biosimilars are expected to generate revenue in the $25-35 billion range by 2020.
Many companies have biosimilars in their pipelines, but Novartis is a clear leader with an advanced biosimilar pipeline and products already approved and marketed worldwide, part of an effort to compensate for the loss of revenue due to the expiration of patents on blockbuster drugs and providing cost-effective therapies for rare and life-threatening diseases, according to Forbes. Novartis’s biosimilars are marketed by the company’s Sandoz generic division. It was the first manufacturer in the world to have a biosimilar approved and commercialized, and has approved biosimilars in over 75 countries and 250 million patient-exposure days worldwide.
Sandoz/Novartis has received FDA approval for two of the four currently approved biosimilars: Zarxio, a biosimilar of Amgen’s Neopogen (filgrastim-sndz)--the first biosimilar to be FDA-approved--and Erelzi, a biosimilar of Amgen’s Enbrel (etanercept-szzs). However, because of Amgen’s continuing patent litigation against Erelzi, Sandoz recently announced that it will not be marketing Erelzi before 2018 at the earliest.
Novartis has plans to launch four additional new biosimilars by 2020: biosimilars of Humira (adalimumab), Neulasta (pegfilgrastim), Remicade (infliximab), and Rituxan (rituximab). Worldwide sales of these drugs and Enbrel was over $44 billion in 2015; if Sandoz gains even a small piece of that revenue, biosimilars would become an important part of the Novartis portfolio. The company’s biosimilar pipeline includes oncology and immunology molecules and hematology drugs. In 2015, Sandoz’s biosimilars unit earned $772 million (total revenue for the company’s biopharmaceutical unit was $9.2 billion).
Novartis’ first US-approved biosimilar Zarxio was introduced in Europe in 2009. In 2013 the biosimilar became the first to pass a reference product in market share, and is prescribed to more than 100,000 patients in more than 40 countries worldwide.