It was announced on Friday that Teva and Amgen have settled their patent litigation over Neupogen (G-CSF) and Neulasta (PEG G-CSF), with Amgen agreeing that Teva can launch its products on 10th November 2013, or earlier if another company’s biosimilar is approved before then. This is a big step forward for Teva, which filed its own version G-CSF, Neutroval, with the FDA in November 2009 and expects to file a pegylated version, Neugranin, later this year. Analysts appear unsurprised that Amgen has chosen to settle rather than fighting Teva through the courts, but its behaviour now is in stark contrast to its aggressive legal response when Roche tried to launch pegylated EPO in the US. Indeed, Neulasta doesn’t even go off patent until 2015, so Amgen is actually giving Teva early entry, assuming that Neugranin gets approval from the FDA. Not that this is a given. Neutroval received a complete response letter in September 2010, albeit without any requirement for additional clinical trials, and Teva has said nothing since about its progress. It is also still struggling to get its version of Lovenox approved by the FDA, a year after Sandoz launched generic enoxaparin, suggesting that biologics may be proving a bit trickier than Teva first imagined. We would also note that Amgen itself plans to make an entry into biosimilars, although it has not been specific about which products it intends to target.
Given that Teva has gone down the BLA route with G-CSF (relatively easy to do, given that the development work done on the product in Europe, by ratiopharm, was designed to get it approved as an innovative drug and not as a biosimilar) there is no possibility that its product will be directly interchangeable for Neupogen. This may be one reason why Amgen was willing to settle – it is confident that Teva will take only a small portion of the market since Neutroval will have to be marketed to physicians and Teva currently has little means to do this outside the respiratory and CNS areas. Because G-CSF is mostly used to treat cancer patients, it is unlikely to be the subject of pharmacy substitution, and hospital doctors are currently paid a fixed 6% mark-up on the cost of the drugs that they use, so they have little incentive to use cheaper products. In the case of true generics, the incentive is created by the fact that the generics and the innovator have the same Medicare code, with reimbursement being calculated based on the average price of all the drugs under the code, but with a two-month lag. Consequently, when generics first launch, doctors can buy at the generic price and be reimbursed at the innovator one, which not surprisingly results in rapid uptake of generics. In the case of Neutroval and Neugranin, the coding will be different from that used for Neupogen and Neulasta, so this situation won’t arise. As a result, we expect them to make very little impact on the US G-CSF market. Certainly, the ‘generic’ versions of human growth hormone that are currently on the market (Tev-tropin from Teva and Omnitrope from Sandoz) have negligible market shares. Of course, versions of G-CSF approved via the FDA’s new biosimilars pathway may get the same HCPCS code as the originator, which would have a much bigger impact on the market, but any 351(k) authorisations are still a long way off so we doubt that Amgen is losing much sleep yet.
Posted on 18th July 2011