Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Court Rescinds Marketing Authorization Following Orphan Drug Dispute
The General Court of the European Union has overruled a decision to grant marketing authorization to ASK Pharmaceuticals' Kolbam after concluding the approval was contrary to the terms of orphan drug regulations.
The ruling is the latest twist in a multi-year dispute over the market for cholic acids to treat primary bile acid synthesis. Laboratoires CTRS, after some legal wrangling of its own, won approval to market Orphacol to treat forms of the condition caused by two enzymatic defects in 2013. Around the same time, officials were also ruling on the status of Kolbam, a similar drug that its manufacturer initially wanted to use to treat the same indications as Laboratoires CTRS' therapy.
However, after the Committee for Medicinal Products for Human Use (CHMP) ruled Kolbam was not clinically superior to its rival and therefore could not disrupt its first-mover orphan drug market exclusivity, the focus shifted to three other forms of the same condition. Kolbam was approved in these indications in 2014, prompting Laboratoires CTRS to dispute the ruling on the grounds that the scope of the label raises the possibility the drug will be used in a way that violates its exclusivity.
The General Court has ruled in favor of Laboratoires CTRS, concluding that the wording of Kolbam's Summary of Product Characteristics (SmPC), particularly references to its efficacy against the defects that are exclusive to Orphacol, mean it facilitates the off-label use of the treatment. The European Medicines Agency (EMA) has responded to the ruling by invalidating Kolbam's European Public Assessment Report as the product is no longer authorized in the region.
EMA Notice, Court Ruling
EUnetHTA Starts Collaborative Hepatitis C Drug Comparison to Test Concept of EU-Wide HTA
EUnetHTA has released a draft project plan for an initiative to collaboratively rapidly create a core health technology assessment (HTA) for the new generation of hepatitis C medicines and translate it into local reports.
The initiative is both a pilot project for greater collaboration in the field of HTAs and a way to support national reimbursement decisions for Gilead Sciences' Sovaldi and other highly effective but hugely expensive hepatitis C drugs. Such drugs have created problems for payors on both sides of the Atlantic, a situation that has been exacerbated by the difficulty in comparing the effectiveness of products that are yet to generate significant amounts of real-world evidence.
EUnetHTA is trying to help countries in this regard by comparing Sovaldi with other hepatitis C drugs, from recently approved rivals such as AbbVie's Viekira Pak, to the treatments on which healthcare systems relied prior to the arrival of the next-generation products. The project will rely on indirect comparison methods, such as network meta analysis. EUnetHTA will compare its report to one produced by German drug assessment agency the Institute for Quality and Efficiency in Health Care.
EUnetHTA Project Plan
European Consortium Picks Falsified Medicines Directive Data Hub Vendors
The European Medicines Verification Organisation (EMVO) has named Aegate, Arvato and Solidsoft Reply as the companies to handle data storage aspects of the Falsified Medicines Directive (FMD). Selection of the preferred providers moves Europe closer to the adoption of a verification system.
EMVO has worked on selecting the providers since February, when it was created by five European trade groups to do some of the heavy lifting involved with creating a system that complies with the FMD. The main thrust of EMVO's approach has been to ease the process for the national stakeholder organizations that will ultimately take responsibility for managing the FMD systems. This entailed establishing a blueprint for implementation, support plan and list of preferred providers.
National stakeholders are now being encouraged to assess the three service providers and select the one that best meets their needs. Once up and running, the system will see each pack of medicines serialized during manufacturing and then verified by pharmacies when they are given to patients. The success of the system rests on the repositories, which will connect to the IT infrastructure of manufacturers, parallel distributors, wholesalers and pharmacies to keep track of all the data.
Securing Industry, Press Release
MHRA Creates Blog to Discuss Inspection and GxP Issues
The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has started an inspectorate blog on which it will discuss topics related to good practice (GxP), starting with a series of posts on how organizational behavior and system design affect data integrity.
Mark Birse, group manager, inspectorate at MHRA, outlined the idea in an introductory post. The idea is to give MHRA inspectors another way of communicating with the companies they regulate, something Birse hopes will keep the industry up to speed on changes to guidance and requirements. Posts on compliance management issues, drug shortages, significant inspection findings and other topics are in the works.
The first output from the blog is scheduled to be three posts on data integrity, an area in which Birse said increased focus has led to serious consequences for some companies. Birse's statement applies to a sizeable minority of manufacturers in India. Such companies — and those seeking to avoid following in their footsteps — will now have an opportunity to learn how MHRA inspectors think organizational behavior and system design can prevent data integrity failings.
Dave Ricks, a senior vice president at Eli Lilly, has said the Transatlantic Trade and Investment Partnership (TTIP) is needed to drive harmonization of regulations in the United States and Europe. Ricks views TTIP as a way to force regulators to abandon their "entrenched positions" that have hindered 25 years of attempts to harmonize standards voluntarily. in-PharmaTechnologist
EMA has banned China's Zhuhai United Laboratories from importing certain active pharmaceutical ingredients (APIs). The regulator withdrew Zhuhai's licenses for the APIs, which include forms of the antibiotic amoxicillin, after Romanian inspectors faulted the aseptic practices at its plant. Zhuhai sold the APIs in Romania, France and the United Kingdom. FiercePharmaManufacturing
The United Kingdom's National Institute for Health and Care Excellence (NICE) has recommended biosimilar versions of Remicade over the reference product. NICE's decision was shaped by the cost of the medicines. With NICE concluding that biosimilars from Hospira and Napp are identical to the reference product, their 10% price discounts makes them its products of choice. PMLiVE
EMA has published a concept paper covering environmental risk assessments for plants producing veterinary medical products. The paper is intended to start to address areas outside the scope of a 2012 reflection paper, in which EMA outlined a way to handle Phase II Tier B of the environmental risk assessment but overlooked other tests and specific scenarios. EMA Concept Paper
MHRA and other authorities have collaboratively seized almost 21 million doses unlicensed and fake medicines valued at $80 million in the latest phase of Operation Pangea. The United Kingdom regulator accounted for almost one-third of the volume and value of products seized and removed more than 320 videos from YouTube. Press Release
Politico reports three women are being considered for the top job at DG Sante. Marianne Klingbeil , Ruxandra Draghia-Akli and Monique Pariat are all reportedly in the running, as is the existing acting director Ladislav Miko. Politico
EMA has released a draft question and answer document about how sodium is affected by changes to excipient labeling regulations. Draft Q&A