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Novartis Resubmits BLA to FDA for Biosimilar of Neulasta

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Novartis AG’s (NVS - Free Report) generic arm, Sandoz, resubmitted its Biologics License Application (BLA) for a proposed biosimilar of Neulasta to the FDA.

The BLA was resubmitted to the FDA to address the issues mentioned in the complete response letter (CRL) received in June 2016. The resubmission includes new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study.

We note that Neulasta is a long-acting version of Neupogen and is used primarily to help reduce the chance of infection due to a low white blood cell count in patients with certain types of cancer (nonmyeloid), who receive anticancer medicines (chemotherapy) that can cause fever and reduce blood cell count.

We note that Sandoz is one of the strongest players in the biosimilars market. Ziextenzo, the biosimilar of Neulasta, has already been launched in Europe in November 2018. The company has three approved biosimilars in the United States and markets eight biosimilars in the European Economic Area (EEA).

Among these, Hyrimoz, a biosimilar of Humira, was launched in the EU in October 2018. It is also approved in the United States. However, Novartis cannot launch Hyrimoz in the United States until October 2023, per a settlement with AbbVie, Inc. (ABBV - Free Report) . Zessly, a biosimilar of Remicade, was launched in the EU in November 2018.  The FDA approved Erelzi, a biosimilar of Enbrel, in 2016 but the launch is pending litigation with Amgen, Inc. (AMGN - Free Report) .

Meanwhile, Sandoz received a CRL from the FDA in May 2018 for a biosimilar of Rituxan and has decided thereafter not to pursue it any further as of now.

We remind investors that the Sandoz business has suffered significant declines in sales and profits in the United States due to increased competition in its product segments. The company has agreed to sell the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo Pharma USA Inc.

Shares of the company have gained 12.9% in the past six months compared with the industry's 3.6% growth.

The last year was a transformative one for Novartis, as it restructured its business to become a core drug-focused company, powered by data and digital technologies. Novartis acquired U.S.-based clinical-stage gene-therapy company, AveXis, Inc in 2018. The company also acquired Endocyte to expand expertise in radiopharmaceuticals. We expect more acquisitions in the coming months, as the company looks to further restructure its business.

Approval of new drugs and label expansion of existing drugs bode well for Novartis, as it looks to streamline its business. The company sold its stake in consumer healthcare joint venture to GlaxoSmithKline (GSK - Free Report) for $13 billion.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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