Posted 16 February 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Biosimilar Trade Group Pressures Ireland to Boost Access Ahead of Policy Shift
Medicines for Europe has called on Ireland to adopt policies that increase uptake of biosimilars in the country. The lobbying effort comes in the run up to publication of a government consultation document on the legal actions Ireland needs to take to encourage greater use of biosimilars.
Biosimilars are available in Ireland. However, as Medicines for Europe and its Irish associate Health Enterprise Alliance see it, existing policies act as a barrier to uptake. Medicines for Europe, a trade group representing biosimilar manufacturers, wants Irish Health Minister Simon Harris to remove the barriers and, in doing so, increase access to more of these low-cost biologics. The trade group thinks Harris and his colleagues should look to mainland Europe for inspiration.
“Ireland needs to raise its game in biosimilar medicines,” Adrian van den Hoven, director general of Medicines for Europe, said. “EU regulatory agencies and medical societies such as EULAR, ECCO or ESMO are widely supportive of physician-led switching based on the wealth of clinical experience and data available on the 10 years of biosimilar medicines.”
Publication of the statement by Medicines for Europe comes the month before Ireland is due to start a consultation on its national biosimilar policy. Harris teased the upcoming publication of the consultation document in a speech at an event hosted by Healthcare Enterprise Alliance. One way to increase uptake would be to allow and encourage the interchangeability of biosimilars and their reference products, but Harris is yet to commit publicly to taking this approach.
“Firstly, we must assess the clinical impact of patients being switched back and forth between a biologic and a biosimilar medicine and the safety, efficacy and the traceability of the medicine in the event of a side-effect where switching has taken place,” Harris said. “Secondly, we need to consider whether or not we as a country consider that pharmacy level substitution is appropriate. This will require extensive consideration as to whether or not the prescriber and patient should always be included in any decisions around switching between a biologic and biosimilar medicine.”
The discussions about the future of biosimilar regulation in Ireland — which Harris sees as part of a one-year-long process of legislative revision — are taking place against a backdrop of reports about the slow rate of uptake to date.
Earlier this month, the Irish Times reported three packets of a biosimilar copy of Enbrel were sold in the last two months of 2016. Pfizer sold 10,000 packets of the originator biologic over the same period (and won approval for its Enbrel biosimilar on Wednesday), albeit at a 30% reduction for the originator following the entry of a biosimilar competitor.
Press Release, Harris Speech, Irish Times
EDQM Adapts Certificate of Suitability Process to new Views on Starting Materials
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has revised its policy on the assessment of Certificates of Suitability (CEPs). EDQM made the changes to bring the document in line with current thinking on starting materials and other topics.
CEPs show the compliance of a material with its European Pharmacopoeia monograph. Producers of active pharmaceutical ingredients (APIs) apply for the certificates to demonstrate the suitability of their products for use in medicines. European officials introduced the CEP procedure in 1994, since when they have periodically assessed the process in light of new knowledge and thinking.
The latest revision is, in part, an attempt to keep the process up to date with the move to redefine starting materials. This redefinition has forced applicants to look at earlier points in the synthetic route when defining their starting materials.
EDQM has also moved to a three-round policy for assessing new, revised and renewed filings for CEPs, reflecting the model used by other European procedures. After reviewing a filing, EDQM will either grant the request or seek additional information. Following submission of this information, EDQM may reject or accept the filing, or ask for the applicant to update sections of module 3.
EDQM Notice, Revised Document
PRAC Links J&J Diabetes Drug to Raised Risk of Lower Limb Amputation
The Pharmacovigilance Risk Assessment Committee (PRAC) has warned Johnson & Johnson’s Type 2 diabetes drug canagliflozin may raise the risk of toe amputation. EMA’s PRAC based the position on data from two ongoing trials of Type 2 diabetics at high risk of heart problems.
Type 2 diabetics whose disease is poorly controlled are at risk of infections and ulcers leading to amputations, particularly if they also have problems with their heart and blood vessels. Data from the placebo-controlled trials suggest canagliflozin, also known as Invokana, may increase this risk, although PRAC is yet figure out why.
In response, PRAC has recommended listing lower limb amputation as an uncommon side effect. This status, which means it affects between one and 10 patients in every 1,000, is intended to alert doctors to the risks faced by patients who develop infections, skin ulcers and other complications affecting their feet. PRAC wants doctors to consider stopping use of canagliflozin in such patients.
The warning recommendation extends to dapagliflozin and empagliflozin. No studies have linked these diabetes drugs to risk of lower limb amputation, but, as they belong to the same class of medicines as canagliflozin, EMA is wary of the danger. PRAC has previously linked the class of medicines, SGLT2 inhibitors, to dangerously high levels of blood acids.
Lords Back Change to Drug Pricing Bill to Appease Pharmaceutical Industry
The House of Lords has backed an amendment to a drug pricing bill that is close to becoming law in the UK. Support for the amendment is underpinned by a belief the UK must show its support for the life sciences sector while working to control the amount it spends on medicines.
Politicians introduced the bill last year to close loopholes that stop the government from acting against companies that dramatically raise the price of generic medicines in some situations. Drugs targeted by the bill include some of those that have seen 1000% or more in price increases in the past decade. However, some members of the House of Lords think the bill sends out the wrong message to the drug industry at large at a time the UK is courting the sector.
“I do not doubt the government’s commitment to the life sciences. However, they have not convinced the industry with the bill. They seem to be sending out separate messages,” Lord Warner said at the end of a debate about the amendment.
To clarify the UK’s commitment to life sciences, members of the House of Lords have proposed and voted in favor of an amendment. The proposed text states the UK government “must have full regard to the need to ... promote and support a growing life sciences sector ... and ensure that patients have rapid clinical access to new clinically effective and cost-effective medicine.”
The House of Lords voted in favor of the amendment 253 to 208.
Other News:EMA has published a summary of the WEB-RADR workshop it hosted last year. The event brought together people working on the use of mobile technologies to gather reports of adverse events. Topics discussed at the event included the use of social media monitoring to support the detection of signals. Executive Summary