Novartis’ generics division, Sandoz, has announced that it plans to push five new biosimilar drugs through the product pipeline all the way to approval by 2020. The company says that the expansion will further reaffirm Sandoz’s commitment to providing less expensive versions of biologic drugs.
Sandoz has plans to file applications for marketing approval for 11 biosimilar drugs in both the US and in Europe, by the end of 2017. The company has already reached the half-way point by filing six of the 11 biosimilar applications.
Sandoz’s current biosimilar offerings include Omnitrope (somatropin) and Binocrit (epoetin alfa) in Europe, and Zarxio (filgrastim-sndz) in the US. If all of the company’s biosimilar applications are approved by regulatory agencies, Sandoz may have nearly three times as many products on the market in just four years.
Novartis has also pledged to spend $1 billion on biosimilar manufacturing between 2010 and 2020. In the past six years, the company has already expanded operations at its manufacturing plants in Schaftenau and Kundl, Austria.
Biosimilars are the generic versions of biologic drugs, and are considered to have clinically comparable effects as their branded counterpart. Once the patent-exclusivity period for a given biologic has expired, biosimilars companies are free to develop less-expensive, copy-cat versions.
Investment into biosimilars has been spurred on by the recent patent expirations for top-selling biologics, including Humira and Remicade. While many biosimilars have been long-established on the European market, the US is only just starting to enter the space.
Novartis’ Zarxio – a biosimilar of Amgen’s biologic drug, Neupogen – was the first ever biosimilar to win US Food and Drug Administration (FDA) approval in 2015. The regulatory agency has since approved a Remicade biosimilar developed by Celltrion and Pfizer.
Novartis plans to release biosimilar versions of Enbrel, Humira, Neulasta, Remicade, and Rituxan over the next few years. In 2015, those five biologics generated $44 billion in worldwide revenue.
“Biologics have revolutionized treatment of many disabling and life-threatening diseases but far too many people who need these medicines are not able to access them,” said Richard Francis, CEO of Sandoz. “At Sandoz, we are committed to significantly broadening patient access to biologics with a series of major biosimilar launches over the next few years.”