European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

Posted 01 September 2016 | By Nick Paul Taylor 

European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda

The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement. 

When the officials signed the grant agreement on 25 August, it marked the start of a 30-day window in which other organizations need to commit to the program. Once the window closes, Joint Action 3, EUnetHTA’s term for the third phase of its strategy, will officially begin. Joint Action 3 is due to run from 2016 to 2020, a period in which EUnetHTA wants to define and adopt “a sustainable model” for HTA cooperation in “scientific and technical” areas.

In practice, this means EUnetHTA will focus its energy on developing ways to share objective, reliable, timely and comparable information of relevance to HTAs that choose to participate in the scheme. EUnetHTA has created seven work packages covering dissemination, evaluation, joint production and other topics to advance it toward this overall goal. The work packages will tap into the capabilities of HTAs and research sites in the United Kingdom, the Netherlands, Spain and other European nations.

EUnetHTA now involves 77 organizations from 29 countries, a breadth that adds to the impression that it can eliminate some of the duplicated work inherent in the HTA system today. The system as it stands has aggrieved multiple drugmakers in different ways —  Novo Nordisk took its complaints to the Directorate General for Health and Food Safety in June — but member states’ desire to retain control over aspects of the HTA process has hindered harmonization efforts.  

EUnetHTA Statement

NICE Backs 3D Modeling of Heart Disease in Draft Recommendation

The UK’s National Institute for Health and Care Excellence (NICE) has backed the use of 3D modeling to identify heart disease in draft guidance. If finalized, NICE’s recommendation would see the use of software that models blood vessels become part of routine clinical practice in the UK.

HeartFlow FFR CT, the technology being evaluated, is designed to turn data from a cardiac CT scan into a 3D model of a patient’s blood vessels. By providing doctors with a virtual look inside a patient, HeartFlow thinks its software can enable the identification of narrow blood vessels that may require treatment. Notably, the software does this without the need for invasive investigations, a fact that contributed to NICE lending its preliminary support to the use of the technology.

“The preliminary view of the independent committee is that HeartFlow FFR CT is innovative and using it in practice may simplify the series of tests used to diagnose the condition,” Carole Longson, director of the NICE Centre for Health Technology Evaluation, said. “[The committee] concluded that the device is highly accurate in diagnosing coronary artery disease, and that it has the potential to reduce the need for invasive coronary investigations, which is good news for the patient.”

The recommendation is good news to healthcare budget holders in the UK, too. NICE calculates the use of FFR CT will lower the cost of testing patients for heart disease by £214 ($281). Depending on the functional imaging technique used, the saving amounts to a 16% to 17% decline in per-patient testing costs. HeartFlow cut the cost of its technology from £888 to £700 during the assessment. NICE calculated the technology would save the healthcare system money at either price.

Press Release, Draft Guidance

EMA Starts Review of Biosimilar Herceptin After Accepting Filing

The European Medicines Agency (EMA) has begun reviewing a biosimilar copy of Genentech’s breast cancer blockbuster Herceptin. EMA started the review after accepting a submission for approval from Mylan for the Herceptin biosimilar it developed with Biocon.

Securing EMA acceptance of the application for review positions Biocon and Mylan at the front of the race to bring a biosimilar version of Herceptin to market in Europe. Biocon and Mylan think they are the first companies to get this far through the approval process, but they are very unlikely to be the last. Allergan and Amgen are developing a copy of Herceptin in their biosimilar collaboration. Pfizer and Samsung Bioepis both have their own programs, too.

Mylan has based its submission around a pharmacokinetic study designed to show the biosimilar is bioequivalent to Herceptin, and a clinical trial that compared the efficacy, safety and immunogenicity of the copy to the innovator. That clinical trial, data from which were presented at the American Society of Clinical Oncology meeting in June, showed the biosimilar could match Herceptin. In doing so, the data positioned Biocon and Mylan to expand beyond their initial focus on emerging markets.

“Following our successful commercialization in India and emerging markets, we look forward to our pending launch in Europe,” Rajiv Malik, president of Mylan, said. “Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs.”

Press Release

NICE Decision Gives Patients with Uterine Fibroids a Nonsurgical Treatment

NICE has added Allergan and Gedeon Richter’s Esmya to the uterine fibroid treatment pathway. The inclusion of the drug in the pathway gives women in the UK a first-line nonsurgical intervention for uterine fibroids in certain situations.

Doctors are now recommended to offer up to four 5 mg courses of the drug, also known as ulipristal acetate, to women who have fibroids of 3 cm or more in diameter and heavy menstrual bleeding. This only applies to women who also have hemoglobin levels of 102 g per liter or below. For women with hemoglobin levels above this cutoff point, NICE is only advising doctors to consider offering the drug. Esmya is the only pharmacological intervention recommended to treat fibroids of this size.

The recommendation carries a caveat. NICE is also advising doctors to tell women about the side effects associated with Esmya. NICE lists endometrial thickening and amenorrhoea — the absence of menstruationas “very common” unwanted outcomes of the drug. Common side effects include vertigo, nausea, abdominal pain, hot flashes, headaches and weight gain. In rare cases, the drug has been linked to uterine hemorrhages and ruptured ovarian cysts.

While the list of side effects is more extensive than those associated with the interventions used to treat smaller fibroids, NICE nonetheless regards the risk-benefit balance as being favorable. Prior to the development of Esmya, surgery was the only option for many women. Surgical interventions carry their own risks, and from the perspective of the UK healthcare system are a costly option. As such, the use of Esmya could save the UK National Health Service money.

NICE Guidance

Other News:

The European Commission has awarded orphan drug status to Alexion Pharmaceuticals’ ALXN1007 in graft-versus-host disease. ALXN1007, a monoclonal antibody targeting complement protein C5a, will now be eligible to receive certain benefits and incentives the European Union uses to encourage the development of drugs against rare diseases. The drug is in Phase II. Press Release

Celltrion is claiming its biosimilar copy of Johnson & Johnson’s Remicade was prescribed to more than 105,000 patients from its introduction in August 2013 to the end of June 2016. Based on sales figures from J&J, Celltrion estimates it has captured approximately 40% of the European market for the rheumatoid arthritis drug. Article


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