Regulatory Focus™ > News Articles > European Regulatory Roundup: EMA Finalizes its Biosimilars Guidance (15 January 2014)

European Regulatory Roundup: EMA Finalizes its Biosimilars Guidance (15 January 2014)

Posted 15 January 2015 | By Nick Paul Taylor 

European Regulatory Roundup: EMA Finalizes its Biosimilars Guidance (15 January 2014)

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

EMA Finalizes Another Piece of its Revised Biosimilars Guidance

The European Medicines Agency (EMA) has finalized another piece of its guidance on biosimilars. In the latest update to the pioneering guidance documents EMA introduced in 2005, the regulator details the preclinical and clinical tests developers should perform to demonstrate biosimilarity.

EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted the final text just before the holidays, less than two months after it signed off on a final version of another updated biosimilar guidance document. The latest guidance adds details of EMA’s expectations for pharmacodynamic studies, trial design, pharmacovigilance and other areas that have evolved over the past decade.

The regulator has also added a section on the extrapolation of data from one indication to another and extended its recommendation of a stepwise approach to cover preclinical and clinical studies. EMA will accept extrapolation of safety and efficacy data between indications, but only when justified scientifically. Extra data will be needed for some products, such as those with multiple active sites.

EMA will begin enforcing the new guidance on 1 July 2015.

EMA Guidance

SCENIHR Posts Opinion on Risks of Nanomaterials in Medical Devices

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its opinion on the health effects of nanomaterials in medical devices. SCENIHR recommends a phased approach to assessing the risks, which it thinks mainly stem from the release of free nanoparticles.

SCENIHR finalized its opinion after consulting with 11 organizations and individuals, including the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The process led to a document that recommends a four-phase approach to risk assessment, covering particle release and persistence, hazard assessment and risk characterization.

The steps are intended to show whether the device is likely to release nanoparticles, as well as how long they will last and what risks they pose. This information will inform the final risk characterization, which should be compared to the dangers posed by similar devices that are free from nanomaterials. SCENIHR recommends including the potential benefits to patients in this final analysis.

In the long term, SCENIHR hopes understanding of nanomaterials will enable accurate predictions of the nature, distribution, tissue levels and potential persistence of nanoparticles. However, the gaps in knowledge today necessitate the evaluation of each device on a case-by-case basis.

SCENIHR Opinion

Industry Pushes for Reform of NICE After UK Drops Cancer Drugs

The decision by England's National Health Service (NHS) to cut 16 drugs covering 25 indications from its Cancer Drugs Fund (CDF) has triggered angry reactions at companies and trade groups. NHS England made the decision, but the criticism it provoked extended to the pace of reform at the National Institute for Health and Care Excellence (NICE).

CDF gives NHS an extra pool of money to pay for cancer drugs that were rejected by NICE. Despite the budget for CDF growing from £200 million ($304 million) in 2013 to a forecast £380 million for the coming fiscal year, NHS needs to stop covering some drugs if it is to pay for new products. The budget constraints have prompted some to attack what they perceive to be the source of the issue: NICE.

“Such a re-evaluation process would not be necessary in the first place if NICE quickly evolves the way it evaluates cancer medicines as part of more fundamental reforms,” Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry, told The Financial Times. NICE is currently being reviewed as part of a periodic evaluation of health institutions in the United Kingdom.

The Financial TimesI NHS Statement

EMA Rethinks Advice on Safety of Estragole, Menthofuran and Pulegone

EMA has posted new public statements on the safety of herbal products containing estragole, menthofuran and pulegone. The latest documents come 10 years after EMA last reviewed the topics and include stronger warnings about the products’ risks.

The regulator presented the conclusions of its review in two documents, one covering estragole, the other focusing on menthofuran and pulegone. For each class of product, EMA now recommends keeping exposure levels as low as practically achievable. Estragole is linked to genotoxic carcinogenicity.

Reports have also linked menthofuran and pulegone — which are found in oils of peppermint and mint — to carcinogenicity, but the mechanism of action is unclear. EMA wants to raise awareness of the link to liver reactions, see more focused pharmacovigilance and make companies show their products comply with exposure limits.

Estragole I Menthofuran and Pulegone

PRAC Recommends Revised Warnings for Ambroxol and Bromhexine

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)has recommended changes to the labels of drugs that contain ambroxol and bromhexine. PRAC made the recommendations after reviewing the risk of severe skin reactions and other allergic responses.

Belgian regulator AFMPS first alerted EMA to the risks after receiving reports of patients experiencing allergic responses and skin reactions following treatment with ambroxol. A review by PRAC concluded the risks posed by ambroxol and bromhexine — another drug used to clear mucus from airways — are small, but significant enough to warrant changing the label.

If EMA adopts PRAC’s recommendations, the labels of drugs containing ambroxol and bromhexine will feature more details on the potential for allergic responses and a new section covering skin reactions. PRAC recommends physicians discontinue treatment immediately if a patient experiences severe skin reactions, such as erythema multiforme and Stevens-Johnson syndrome.

PRAC Recommendation

Other News:

MHRA has awarded Bristol-Myers Squibb’s Opdivo Promising Innovative Medicine (PIM) status. The decision puts the PD-1 inhibitor on the first step of the United Kingdom’s new fast-track approval process. If Opdivo fulfills the promise it has shown to date, MHRA may agree to make the drug available to patients before it is officially licensed. PMLiVE

The Committee on the Environment, Public Health and Food Safety (ENVI) has commented on the Regulatory Fitness and Performance Programme (REFIT). ENVI is concerned the initiative’s focus on cutting red tape could lead to deregulation of health and other sectors. When legislation is assessed under REFIT, ENVI wants to ensure health factors are taken as seriously as economics. Draft Opinion

MHRA has warned counterfeiters are changing their tactics. The regulator shut down 1,600 sites selling fake drugs and seized counterfeits valued at £3 million ($4.5 million), but faces a new struggle with social media. Last year MHRA took down 19,000 online videos and continued to cooperate with YouTube, Amazon and eBay. in-PharmaTechnologist

In 2013, EMA took 57% longer to approve medicines than the US Food and Drug Administration, making it the second slowest of the six major regulatory authorities. However, approval times in Europe were more consistent than in other regions. CIRS Analysis I Regulatory Focus

EMA has shared three International Conference on Harmonisation (ICH) documents. The texts cover electronic transmission of individual case safety reports (ICSRs), electronic common technical documents (eCTD) and elemental impurities. ICSR I eCTD I Impurities

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has been re-certified as ISO 9001:2008 compliant. French accreditation body AFAQ awarded the status to EDQM after conducting a three-day audit. EDQM Statement

Covidien received a CE Mark for its drug-coated balloon to treat peripheral artery disease. The device is set to be sold to Spectranetics to allow Covidien to comply with the antitrust terms of its $43 billion merger with Medtronic. FierceMedicalDevices


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