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Novartis has announced the launch of the SURPASS Study, a head-to-head superiority trial of secukinumab (Cosentyx®) versus their own proposed biosimilar of adalimumab, in patients with ankylosing spondylitis. The SURPASS Study is part of a larger clinical program for secukinumab, which includes the EXCEED Study, a head-to-head superiority trial of secukinumab versus Humira® itself (originator adalimumab) in patients with psoriatic arthritis. Announcement of the SURPASS Study follows the release of November 2017 data confirming the lack of clinically meaningful differences in patients who switched back and forth between Humira® and Novartis' adalimumab biosimilar multiple times, and those patients who stayed on the biosimilar throughout the study. Despite the potential of their adalimumab biosimilar to eventually capture a share of Humira's® market, Novartis has clearly decided to prioritize Cosentyx®, which has already become a top-seller since its launch in 2015. The intention behind the EXCEED and SURPASS Studies seems to be to demonstrate that not only is Cosentyx® clinically superior to Humira® itself, but is also sufficiently superior to lower-priced adalimumab biosimilars that their cost savings cannot be justified. This is the first time a biosimilar has been used as a comparator in a major study versus a different originator.
The news of Novartis' attempt to directly challenge Humira® comes just after AbbVie's announcement of a 9.7% price rise for Humira®, which has more than doubled in price since 2012. According to one analyst, the latest price increase could add $1.2 billion to the US healthcare system's drug costs in 2018, especially since AbbVie has used patent litigation to prevent adalimumab biosimilars from reaching the market before 2023.
Sandoz has announced results from a new Phase 1 crossover study showing that its proposed pegfilgrastim biosimilar (LA-EP2006) matches the originator, Amgen's Neulasta®, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy volunteers. The data were presented at the San Antonio Breast Cancer Symposium in December 2017. The US Food and Drug Administration (FDA) had originally rejected Sandoz's pegfilgrastim biosimilar in July 2016, issuing a Complete Response Letter (CRL). The European Medicines Agency's (EMA's) review of LA-EP2006 is still underway, but Sandoz claims these new data add to the totality of evidence in support of the product. There are no pegfilgrastim biosimilars approved at present in either the US or Europe. Biocon withdrew its EMA application for its prospective pegfilgrastim biosimilar following an FDA CRL (as well as concerns from European regulators) regarding the quality of its manufacturing plant in Bangalore, India, but it since claims to have addressed these concerns and resubmitted its EMA application in November 2017. Meanwhile, the EMA has also accepted Mumbai-based pharmaceutical company USV Pvt Ltd's marketing application for a pegfilgrastim biosimilar.
The US Court of Appeals for the Federal Circuit (CAFC) has decided a key remaining question in the long-standing legal battle between Amgen and Sandoz over whether a biosimilar maker ever needs to give the originator manufacturer 180 days' notice of its intention to launch following FDA approval. The original case was escalated to the Supreme Court, which ruled, in June 2017, that Sandoz was not obliged to wait an additional 180 days after licensing before its biosimilar product Zarxio™ could be commercialized. Amgen then sought to leverage individual state laws to impose this notice period at a local level – but the CAFC has now confirmed that Sandoz cannot be compelled under any state law to give Amgen 180 days' notice of launching Zarxio™, and that state laws cannot preempt federal laws in this instance. Alan Clement, Chair of the Intellectual Property Department at the law firm Locke Lord, observed that, following the Supreme Court ruling, "the CAFC has closed the door on what remedies remained available to a brand biologic company in terms of a biosimilar applicant who is refusing to engage in the 'patent dance' under the BPCIA." A Sandoz spokesperson added: "While reference medicine manufacturers will no doubt try and continue to use the legal system to create unnecessary and costly barriers that delay biosimilar approval or availability, this is one of several wins this year that prove the tide is turning for broad-based biosimilar access."
The US Food and Drug Administration (FDA) has granted final approval to its first short-acting follow-on insulin product, Sanofi's Admelog® (insulin lispro injection). Final approval of the drug follows the FDA's tentative approval, granted in September 2017. The agency could not issue its final approval until the resolution of patent disputes with Eli Lilly, the manufacturer of the originator product Humalog®. Because the FDA treats originator insulins as drugs, rather than as biologic products, treatments such as Admelog® are approved through the 505(b)(2) pathway as "follow-ons," not via the 351k pathway as biosimilars. This differs from the situation in Europe where Admelog® is approved by the European Medicines Agency (EMA) as a biosimilar insulin. However, in 2020, products like insulin will all be transitioned to biologics and their "follow-on" versions will then be regulated by the FDA as biosimilars.
The US Food and Drug Administration (FDA) has approved Pfizer's second biosimilar of infliximab, Ixifi™, for all eligible indications of Johnson & Johnson's originator Remicade®. This puts Pfizer in the unusual position of owning two FDA-approved infliximab biosimilars, although the other one – Inflectra® – is in partnership with Celltrion. Pfizer acquired Inflectra® when it bought Illinois-based Hospira in 2015. At the time, Pfizer elected not to discontinue development of Ixifi™, which was already underway, but now says it has no plans to commercialize the product in the US – where the company is already heavily investing in Inflectra® – or in Europe, where it has already sold marketing rights to Sandoz. "We are currently evaluating our strategic options for Ixifi™," a Pfizer spokesman said.
A survey conducted among a sample of Spanish physicians specializing in rheumatology, gastroenterology, and dermatology has revealed a notable lack of knowledge about the fact that licensed originator biologic drugs typically undergo several changes to their manufacturing process, which may affect the quality attributes of the product in potentially clinically meaningful ways. Such knowledge is important to minimize potential distrust of biosimilars among prescribers, who may not realize that originator biologics are inherently variable, and there can be as much difference between an originator biologic before and after major manufacturing changes as there is between a biologic and its biosimilar. Some 63% of respondents were not aware that such manufacturing modifications occur. The remainder were aware – but had little idea how frequently such modifications occur (for example, there have been over 40 for Remicade® and 20 for Humira® since they received a license from the European Medicines Agency [EMA]). In addition, more than 50% of respondents were unaware of the EMA requirement for comparability data in the wake of a manufacturing change, which is akin to some of the data biosimilar developers are expected to submit. While the survey was small (n=35), the authors concluded that educating physicians about these matters may help to contextualize their perception of biosimilars, increase confidence, and improve uptake.
The European Medicines Agency (EMA) has published guidance for biosimilar makers in light of Brexit (the impending departure of the UK from the European Union). Among the considerations addressed are the fact that, once Brexit comes into force on March 30, 2019, all biosimilar applications to the EMA should refer to an originator comparator product authorized in one of the 27 remaining EU Member States or a European Economic Area (EEA) State. Batches of a reference product released by the UK as of March 30, 2019 will not be considered an EEA authorized comparator.