Biosimilars development continues emergence
WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”
He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.
Nobody, not even a sci-fi author like Gibson, can predict the future, except by making projections based on present conditions and circumstances. So it’s impossible to fully determine what form or role new technologies will take decades or years from now.
Just as no one carrying a cumbersome “brick” phone in the 1980s could have foreseen a time when people would watch movies and read news on smart phones with touch screens, nobody today can predict what the healthcare market will look like once cheaper knockoffs of biotech drugs, also known as biosimilars, come into the picture. But with a regulatory approval pathway for them in place, the regulatory environment for biosimilars already is taking shape, and some companies have begun moving in to grab a piece of the market. So it’s certainly possible to make some educated guesses.
Biosimilars, like all biotech drugs, take a lot of money and effort to produce. Building a biosimilar manufacturing plant costs hundreds of millions of dollars, limiting the ability to produce the drugs to those companies that already do—such as Novartis’ generic drug division, Sandoz; Israel-based Teva Pharmaceutical Industries; and U.S.-based Hospira—and those that have enough money to invest, such as Mylan. Thus, as such analysts as IMS Health VP industry relations Doug Long have told Drug Store News, the pool of companies making biosimilars probably will remain small. Nevertheless, they still may follow the same path as the emerging technologies mentioned earlier.
Top 15 U.S. pharmaceutical products by sales*Top 15 U.S. therapeutic classes by sales*PRODUCT20092008CLASS20092008Lipitor$7.5$7.8Antipsychotics, other$14.6$14.2Nexium6.35.9Lipid regulators14.314.5Plavix5.64.8Proton-pump inhibitors13.613.8Advair Diskus4.74.4Antidepressants9.99.5Seroquel4.23.8Angiotensin II antagonists8.47.5Abilify4.03.0Antineo monoclonal antibodies8.07.3Singulair3.73.5Antiarthritis, biol resp mod6.35.6Actos3.43.1Erythropoietins6.36.9Enbrel3.33.1Analogs of human insulin6.35.0Epogen3.23.0Antiplatelets, oral6.05.2Remicade3.23.0Analeptics5.84.7Crestor3.02.1Steroid, inhaled bronch5.54.8Avastin3.02.5Seizure disorders5.39.6Neulasta3.03.0GI anti-inflammatory4.94.3Oxycontin2.92.3Codeine and combinations4.94.2TOTAL U.S. Rx MARKET$300.3$285.7TOTAL U.S. Rx MARKET$300.3$285.7*In billionsSource: IMS National Sales PerspectivesFive of the top 15 drugs (in bold), ranked by U.S. sales, were biologics in 2009, and experts expected an increasing share of the top-selling drugs in the United States to comprise biologics over the next several years. At the same time, major therapies in leading therapeutic classes will lose patent protection (in bold), and the blockbuster model of growth will become increasingly difficult to sustain. This trend is leading many large drug companies to pursue biologics as a source of growth, and it could force many generic companies to move up the value chain as well.Market research firm Decision Resources said in a September report that biosimilars eventually would become as uncontroversial as generic pharmaceutical drugs are today. In another report, the firm predicted that biosimilars would prove particularly popular among cancer specialists because of the drugs’ lower clinical trial requirements—and that U.S. oncologists would adopt them faster than their European counterparts because they would require fewer and shorter phase-3 trials before they felt comfortable prescribing them.Meanwhile, manufacturers aren’t waiting around for Univac mainframes to evolve into Apple iPads.Sandoz, the generics division of Swiss drug maker Novartis, has been particularly aggressive in pursuing biosimilars. Sandoz, which already markets biosimilars in Europe and has marketed the biosimilar growth disorder treatment Omnitrope (somatropin) in the United States since 2006, was the first to launch a generic version of Sanofi-Aventis’ blood-thinner Lovenox (enoxaparin sodium) this year. Though the Food and Drug Administration classifies Lovenox as a pharmaceutical, its chemical complexity and manufacturing processes qualify it in many ways as a biologic, and many experts predicted Sandoz’s marketing of its version will help determine the shape of the U.S. biosimilars market and regulatory environment in the future.Teva’s efforts to market a biosimilar of Amgen’s Neupogen (filgrastim) ran into difficulty in September when it a got a complete response letter from the FDA for the drug, which it had planned to market under the name Neutroval; still, a complete response letter merely means that the FDA needs additional information before it can approve a drug. So Teva still has ample opportunity to win approval.Pfizer, the world’s largest drug maker, sees promise in the field as well. Last month, it inked a deal with Indian bio-tech company Biocon to make biosimilars of popular insulin analogues to treat Type 2 diabetes, including versions of Sanofi-Aventis’ Lantus (insulin glargine [rDNA origin]), Novo Nordisk’s NovoLog (insulin aspart [rDNA origin]) and Eli Lilly’s Humalog (insulin lispro [rDNA origin]).On the regulatory front, the FDA is working on regulations for biosimilars as well. At press time, the agency was planning a Nov 2 meeting in which it would allow drug makers to weigh in on the regulations, including on such issues as interchangeability between biosimilars and their reference products.
NACDS, NCPA claim pharmacy victory after withdrawal of Medicaid program provisions
ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association heralded the withdrawal of two provisions from the Medicaid program that would have had retail pharmacies selling generic drugs at a loss.
The Centers for Medicare and Medicaid Services cut provisions that defined average manufacturer price and determined calculation of federal upper limits. The NACDS and NCPA sued CMS in the U.S. District Court for the District of Columbia in November 2007 to obtain an injunction against the provisions, which the court granted. In response, CMS revised its definition of multiple source drugs in October 2008, though the pharmacy lobby groups amended their lawsuit to block that as well, saying it was still against the law. CMS’ new rule removes that provision as well.
In a joint statement, NACDS president and CEO Steve Anderson and NCPA EVP and CEO Kathleen Jaeger heralded the decision, saying the rule would have reduced patients’ access to pharmacies by cutting reimbursements, thus forcing retail pharmacies to sell generic drugs at a loss.
“We insisted that this policy was not appropriate,” the statement read. “Separately, we also have urged that policy-makers should recognize the ability of pharmacies and pharmacists to help improve health and reduce healthcare costs. We are gratified that this sense is reflected in the pharmacy provisions of the new healthcare-reform law. The new law contains provisions ranging from dramatically reducing the [accelerated manufacturing of pharmaceutical] cuts to advancing medication therapy management, through which pharmacists can help patients take their medications correctly, which is referred to as ‘medication adherence.’”
Roadside announces partnership to further ‘drive’ wellness programs
BOSTON Two companies have formed a partnership to provide services for long-haul truck drivers.
Sleep HealthCenters and Roadside Medical Clinic + Lab announced a partnership Wednesday to provide sleep medicine services as part of Roadside’s driver-wellness programs.
Roadside provides medical services, such as Department of Transportation-compliant physicals, drug testing, driver-wellness programs and sleep services for professional drivers on the highway and at company terminals. Sleep HealthCenters will support Roadside’s programs by providing education, professional diagnosis and treatment support, which will be incorporated into the driver-wellness program.
“You cannot effectively screen, test and treat sleep apnea without addressing and improving drivers’ overall health condition, such as weight, [body-mass index], stress and cardiac strength,” Roadside COO Rob Scheschareg said. “By providing continuous care for drivers for sleep, fitness, health and [Department of Transportation] compliance from the terminal to the highways, Roadside Medical is able to move the needle toward better driver health.”