Another runner drops out of the biosimilars race

by Deborah Toscano 25 Jul 2013
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Teva and Lonza have just announced the termination of their joint venture to co-develop biosimilars, upon the realization that the development costs and time to market were beyond initial estimations. The agreement was formed in 2009. When biosimilars were first a hot topic, it was a common perception that the scenario would be similar to producing generic copies of conventional small molecule drugs, which can typically steal up to 90 percent of the sales of the originator drug with miniscule development costs by comparison. When you combine this erosion potential with the high price tags of biologic drugs, you get a seemingly easy path to billion dollar revenues. However, as many companies are realizing, copying a biologic drug close enough to pass regulatory standards is proving to be more technologically and economically challenging than originally thought. There are many issues at stake, most importantly patient safety, and successful biosimilars will not only have to pass regulatory muster (which is still, at this time, under construction in the U.S.), but will also have to earn the confidence of the prescribing physicians who will rely on strong clinical data and not necessarily only on FDA approval since they will not be, by definition, identical to the originator biologic drug. The required costs and expertise behind the advanced technology, clinical trials, regulatory negotiations, and marketing efforts may be beyond the capabilities of many would-be biosimilar players, and others may decide that application through the full BLA pathway or development of biobetters rather than biosimilars makes better financial sense, since the overall development costs may not be significantly different in the long run. But while some are exiting the playing field, some of the larger, more experienced companies such as Sandoz (Novartis), Hospira, and Pfizer are forging ahead. Sandoz and Hospira already have vast experience launching biosimilars in Europe and elsewhere, (as does Teva) giving them a significant advantage over less experienced players. Sandoz is running several late stage clinical trials ahead of the FDA's final guidance, and marketing giant Pfizer has initiated several early stage clinical trials for their versions of blockbuster monoclonal antibodies such as Herceptin, Rituxan, Remicade, and Humira. Eli Lilly, no stranger to insulin therapy for diabetes, has initiated two late stage trials of their version of Lantus, the blockbuster long-acting insulin from Sanofi.

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