European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017)

Regulatory NewsRegulatory News | 17 August 2017 |  By 

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

Ireland Starts Consultation on Biosimilar Policy, Immediately Receives Pushback From Industry

Ireland has started a consultation on how to increase access to biosimilars. The delayed document calls for feedback on pharmacy-led substitution of biosimilars, quotas for use of biologic copycats and other ways to increase uptake, although doubts remain about whether the government will take actions that improve uptake.

Biosimilars are yet to gain traction in Ireland. While the European Medicines Agency (EMA) has approved close to 30 biosimilars, only 11 are reimbursed by the Irish state. In an attempt to grow this number and control its healthcare costs, the government is considering the gamut of options deployed by other countries. 

The consultation document asks readers to provide their views on prescriber-led switching and pharmacy-led substitution. Health minister Simon Harris has previously expressed reservations about switching and substitution, saying Ireland needs to "assess the clinical impact of patients being switched back and forth" before it liberalizes its rules. A strong response to the consultation could encourage a shift in the government’s position. 

Harris also wants to know what people think about quotas, a tool used in various forms by other European countries to encourage physicians or hospitals to make biosimilars account for a certain percentage of their prescriptions.

These initiatives could help Ireland shed its laggard status in the biosimilar sector, yet some of the government’s critics think it needs to look closer to home for ways to increase uptake.

"[The] most significant obstacle currently to increased uptake of biosimilars is the state itself," trade group Medicines for Ireland told the Irish Times. That comment is a reference to the "blocker clause" built into the supply agreement the government entered into with innovative drugmakers last year. The clause forces manufacturers of branded biologics to cut their prices by 30% when a biosimilar competitor comes to market.

Biosimilar manufacturers argue the automatic cut makes it hard for them to compete. Yet, if they respond by not introducing drugs in Ireland, the price of branded products will remain high. The consultation is seeking feedback on this problem, specifically by asking, "Should the price of the reference treatment be reduced automatically on loss of exclusivity in the Irish market?"

Other questions posed in the consultation document cover inappropriate business practices, tendering , incentives and disincentives and educational programs.

The comment period is open until 22 September.

Press Release, Consultation Paper, Irish Times

EMA Addresses CRO Access to EudraVigilance in Extensive Update to Q&A Ahead of Go-Live Date

EMA has released a major update to its question and answer document on the introduction of EudraVigilance. EMA has nearly tripled the length of the text by writing responses to a slew of questions it has received since it released the original document in July.

The 75-page Q&A now features an expanded glossary, an additional section and new and updated responses to queries categorized under the 10 original subdivisions. The queries were put to the EMA service desk or employees running its pharmacovigilance support webinars by people affected by the anticipated introduction of the EudraVigilance System on 22 November 2017.

New questions answered by EMA include one addressing whether contract research organizations (CROs) and other service providers can access EudraVigilance. Noting some MAHs outsource signal detection, the person asking the question states it is important CROs have "adequate access" to the EudraVigilance Data Analysis System (EVDAS) when it goes live later this year.

The questioner’s preferred solution is to allow CROs to sign up on EudraVigilance independently so they can perform signal screening for multiple MAHs. If that is not possible, the person wants to know how MAHs can register CROs to perform screening for them without granting access at the headquarters level.

Unfortunately for the questioner, neither option is part of EMA’s plans for EudraVigilance.

"The legislation does not foresee access to EudraVigilance data by service providers or CROs," EMA wrote in its reply. "Access to EVDAS data for the purpose of signal management is only granted at headquarter level."

EMA’s EudraVigilance strategy does include provisions for CROs, though. 

"CROs and IT vendors may be registered by a marketing authorization holder, applicant, commercial or non-commercial sponsor as a third party service provider acting on behalf of these organizations by providing services related to EudraVigilance," EMA wrote.

Responsibility for defining how to organize the monitoring of EudraVigilance falls on MAHs.

The question is one of many new queries addressed in a document that has ballooned in length since EMA released the 29-page version 1.0 in July. Further updates are planned. In a response to a new question in the Q&A, EMA said it plans to update the document every month. By keeping the document up to date and asking people to check it before contacting the service desk, EMA is trying to minimize the number of queries it has to field.


EMA Finalizes Reflection Paper on Generic Solid Oral Immediate Release Products

EMA has finalized a reflection paper on dissolution specifications for generic solid oral immediate release products with systemic action. The agency finalized the text after reviewing feedback from companies including AstraZeneca, Bayer and Sanofi.

Officials at the Quality Working Party wrote the first draft of the paper in March 2016 to provide a decision tree for setting specifications to increase the transparency of the process. The comment period closed one year ago. Now, after putting together a 95-page overview of industry comments and EMA responses to them, the agency has finalized the reflection paper.  

One change from the draft version is the title, which was originally "Dissolution specification for generic oral immediate release products." EMA added "oral" and "with systemic action" to the title after the Association of the European Self-Medication Industry, Medicines For Europe and the International Pharmaceutical Federation pointed out the lack of information about suspensions and locally applied products.

EMA has also revised the wording of multiple sections in response to the feedback. Many of the comments were dismissed, though, including those that called for EMA to use the reflection paper as the basis for a formal guideline.

Reflection Paper

German Probe Into Counterfeit Harvoni Discovers Packs of Fake Sovaldi

German regulators have found counterfeit packets of Gilead Sciences’ hepatitis C drug Sovaldi. The Federal Institute for Drugs and Medical Devices (BfArM) discovered the fakes as part of a follow-up investigation initiated after a German pharmacy dispensed counterfeit Harvoni earlier this year.

Sovaldi and Harvoni both contain the active ingredient sofosbuvir. The difference is Harvoni, the successor to Sovaldi, also contains ledipasvir. Both drugs carry price tags that have made them an attractive target for counterfeiters.

BfArM said the packaging of the counterfeit Sovaldi, like that of the fake Harvoni, is similar enough to the genuine product to be difficult to identify as a forgery without a side-by-side comparison. Similarly, the Sovaldi and Harvoni packs both featured genuine, German-market batch numbers.

The notable difference is in the color of the tablets. Real Sovaldi tablets are yellow. The fakes are white. The counterfeit Harvoni was also identified as fake because of the tablet color, as were packs discovered previously in Switzerland.  

BfArM is continuing to investigate the presence of counterfeit hepatitis C drugs in Germany.

BfArM Notice (German)


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