- Novartis on Monday said it plans to launch five new biosimilar drugs by 2020, expanding the Swiss drugmaker's commitment to developing the lower-cost copies of biologic medicines.
- Through its generics division Sandoz, Novartis pledged to file 11 biosimilar applications for marketing approval in Europe and the U.S. by the end of 2017. Sandoz has already submitted six of those 11 planned filings.
- If all of Sandoz's efforts are successful, the plan would nearly triple the number of biosimilars on the market for the company. Sandoz currently markets Omnitrope (somatropin) and Binocrit (epoetin alfa) in Europe, and Zarxio (filgrastim-sndz) in the U.S.
Alongside the commitment to push more biosimilars through the regulatory process, Novartis said its investment in manufacturing for the drugs would total $1 billion over the decade between 2010 and 2020. The company has already expanded its biomanufacturing capacity at its facilities in Schaftenau and Kundl, Austria.
Biosimilars are copies of existing biologic drugs, considered to be highly similar and clinically comparable to their reference products. Like generic versions of pharmaceuticals, companies are allowed to introduce biosimilars following the loss of patent exclusivity for the original biologic.
A wave of patent expiries for some of the top-selling biologic drugs, such as Humira and Remicade, has prompted a number of companies to invest heavily in developing copies.
While biosimilars have been on the market in Europe for a decade, the U.S. is just catching up. Novartis' Zarxio, a copy of Amgen's Neupogen, was the first biosimilar to pass muster with the Food and Drug Administration, winning approval last year.
Since then, the FDA has approved a second biosimilar, a version of Remicade made by the Korean company Celltrion (in partnership with Pfizer).
Novartis said it would launch versions of Enbrel, Humira, Neulasta, Remicade, and Rituxan in the coming years. Together, those five products pulled in $44 billion in global sales.
Last year, global sales of biosimilars earned $772 million for Sandoz, a small but growing portion of the unit's $9.2 billion in annual 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.”
The consultancy IMS Health has predicted the introduction of more biosimilars cost lead to cost savings of over €50 billion over the next five years (potentially even as as high as €100 billion) in Europe and the U.S.