Amgen Nervous As FDA Paves Way For Novartis AG To Copy Drug Neupogen

Published: Jul 28, 2014

FDA Accepts Application For Novartis To Copy Amgen Biotech Drug
FDA Accepts Application For Novartis To Copy Amgen Biotech Drug
July 24, 2014
By Renee Morad, Breaking News Staff

The Food and Drug Administration accepted an application by Novartis’s generics division Sandoz seeking approval for a biosimilar of Amgen’s drug Neupogen, or filgrastim, to treat patients with low white blood cell counts.

Sandoz is the first company to announce that is has filed for approval of a biologic under the new biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

FDA’s approval of the application marks a major step toward increasing patient access to affordable, high-quality biologics in the U.S.

“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S. and we applaud the FDA for its progress in making this a reality,” said Mark McCamish, M.D., Ph.D., head of global biopharmaceutical and oncology injectables development for Sandoz.

“As they’ve done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase U.S. patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system,” McCamish said.

Sandoz already sells a biosimilar version of Amgen’s drug in more than 40 other countries, but the U.S. has lagged behind other markets in establishing a regulatory framework for biosimilars.

Regulators had to devise approval processes for these products since biotech drugs are made from living cells, making it impossible to manufacture exact copies.

Sandoz is the global market leader for biosimilars and claims over 50 percent market share. Under the brand name Zarzio, Sandoz’s version is the number one biosimilar filgrastim globally.

Filgrastim reduces the rate of infections in cancer patients undergoing chemotherapy who experience low white blood cell counts. It is designed for patients with nonmyeloid malignancies receiving myelosuppresive anticancer drugs associated with a significant incidence of sever neutropenia with fever.

The worldwide market for biosimilars is expected to boom in the near future. Global sales for copycat biologicals is projected to reach $35 billion by 2020, according to a report from Allied Marketing Research.

Amgen’s Neupogen brought in $1.4 billion in global sales last year, an 8 percent increase from the same period the year before.

Sandoz’s late-stage pipeline includes biosimilars of Humira, Enbrel, Rituxan and Procrit.

Sandoz, which aims to make medicines that are accessible to more than 90 percent of the world’s population, recorded $9.2 billion in sales in 2013.

Sandoz’s biosimilars sales grew 23 percent to reach $420 million in 2013, driven by strong performance across all brands, according to the company.

Read more recent drug filing news here.

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