Novartis’ (NVS) generic arm, Sandoz, announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of its biosimilar version of Amgen’s (AMGN) Neupogen (filgrastim).
The recommendation for approval of the biosimilar of Neupogen is meant for use in all approved indications.
We note that Neupogen is approved for the prevention of severe neutropenia in breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
Although the FDA is not bound to follow the committee’s recommendation, it generally takes the same into account while evaluating a candidate. Hence, a potential approval might be on the cards.
The positive recommendation was provided on the basis of comprehensive nonclinical, clinical and post-marketing pharmacovigilance data, which confirmed that Sandoz' biosimilar version is highly similar to Neupogen.
We note that Sandoz currently markets its biosimilar filgrastim in more than 40 countries outside the U.S under the brand name Zarzio, generating nearly 7.5 million patient-exposure days of experience. It plans to use the same brand name in the U.S., upon approval.
Biosimilars have been the growth engine of Sandoz, generating double-digit sales in the third quarter driven by continued momentum of three in-market products – Omnitrope (human growth hormone), Binocrit (epoetin alfa) and Zarzio (filgrastim). It currently has six molecules in phase III clinical trials/registration.
Meanwhile, Novartis also announced today that it has signed collaboration and licensing agreements with two biotechnology companies. This includes an agreement with Intellia Therapeutics for the discovery and development of new medicines using CRISPR (lustered regularly interspaced short palindromic repeats) genome-editing technology and with Caribou Biosciences for the development of drug discovery tools.
We cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core portfolio of pharmaceuticals, eye care and generics. Successful development and commercialization of its pipeline is important at this stage as the company faces generic competition for several of its key drugs such as Gleevec, Zometa and Diovan.
Novartis, a large-cap pharma, currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the health care sector may consider Allergan (AGN) and AbbVie (ABBV). Both carry a Zacks Rank #2 (Buy).
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