March 10, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
After a recent ruling by American regulators said Swiss drugmaker Novartis AG may produce the nation’s first biosimilar, a knockoff of Amgen ’s blockbuster treatment Neupogen, Amgen is readying its laboratories to produce its own slate of biosimilars, the company told Bloomberg Tuesday.
“There’s already lots of competition, and we’re used to having to compete on value,” Geoff Eich, executive director of Amgen’s biosimilars division, told the news service. “This is the natural evolution.”
Bloomberg‘s article followed Amgen through its Thousand Oaks, Calif.-based state-of-the-art facility, which the company is readying to produce as many as five biosimilars it says it hopes to have on the market by 2019.
“The 25,000-square-foot (2,300-square-meter) plant is filled with stainless steel tanks that can hold as much as 2,000 liters, each covered with a multitude of dials, buttons and protruding pipes,” said Bloomberg.
“This is where Amgen tests ways to grow Chinese hamster ovary cells to make its own drugs -- and imitations of other companies’ medicine. Taking advantage of a 2010 U.S. law, Amgen has prepared one of the most ambitious pipelines in the industry to develop drugs that mimic its rivals’ biologic treatments.”
Amgen‘s charm offensive for investors worried about its prospects comes less than a week after Novartis won approval from the U.S. Food and Drug Administration (FDA) for the nation’s first biosimilar drug March 6, after the FDA said the company could now sell its white blood cell drug Zarxio.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret Hamburg. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA was only granted the right to review and approve them when Obamacare was passed in 2010.
“The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz, Inc., in a statement. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”
Neupogen raked in $1.2 billion for Amgen last year, a lucrative market that Novartis, and its Sandoz unit that makes Zarxio, are now eyeing eagerly. The FDA said in January that an internal panel seemed inclined to give Zarxio the green light to treat the same five conditions Neupogen does. Sandoz declined to issue a price target for Zarxio.
The company also still faces legal challenges from Amgen, and Sandoz has a district court hearing on the matter March 13. In the meantime, it has agreed to delay its U.S. launch until a ruling is made on a preliminary injunction, or until April 10, whichever comes first.
That uncertainty has Wall Street split on whether to bet on the company now, or take the money and run.
“How much will they lose? How much will they gain?” Eric Schmidt, a senior research analyst with Cowen and Company in New York, told Bloomberg. “It’s one of the biggest debates--if not the biggest-around the stock.”
The FDA granted approval after parsing a Sandoz pivotal head-to-head PIONEER study that showed high similarity between the two drugs. During that study, Zarxio and the reference product both produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17 and 1.20 days for Zarxio and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle 1 was also similar (1.8 days ± 0.97 in ZARXIO arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study.
That data was enough for the FDA to issue the historic decision, opening the floodgates for the biosimilar market to begin flooding American markets, a move that has long been sought by U.S. health insurers and other large health cost payers. With cheaper biosimilar drugs, health costs will come down for patients everywhere, they’ve argued, particularly as expensive patented drugs lose their protection.
Marketed as Zarzio outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide.
Neutropenia, the condition both drugs treat, happens when common white blood cells, neutrophils, dip below healthy levels, most commonly due to cancer treatment or advanced HIV/AIDS.
“Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the US for a variety of reasons, including price” said Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University. “Biosimilars have the potential to increase access and the approval of Zarxio may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice.”
BioSpace Temperature Poll
Vertex Pharmaceuticals made news last week when it terminated leases on three properties in Cambridge, Mass, that freed up 313,000 square feet of space in the Genetown area. The company has spent a significant part of 2014 consolidating its operations on the South Boston waterfront, leasing 291,000 square feet of office space at West Kendall Street in Cambridge’s Kendall Square. So we wanted to ask the BioSpace community: Is Boston going to be getting more biotech leases anytime soon, or fewer tenants?
