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.