Euro Roundup: EMA confirms biosimilars are interchangeable in bid to harmonize European

In Europe


| 22 September 2022 | By Nick Paul Taylor 

The European Medicines Agency (EMA) has confirmed that biosimilars approved in the European Union are interchangeable with their reference medicines. EMA made the clarification in a joint statement with the Heads of Medicines Agencies (HMA) to harmonize a practice that is adopted in many EU countries.
Prior to the statement, many EU member states had independently decided to allow biosimilars to be used interchangeably with their reference products, thereby supporting timely transitions to the cheaper off-patent drugs. The country-by-country approach to decisions on the interchangeability of biosimilars is “causing uncertainty among stakeholders on the use of biosimilars in clinical practice,” according to EMA and HMA, which cited a paper about “the absence of a clear EU-wide position” to support their case.
In light of the concerns about the absence of a clear EU-wide position, EMA has, for the first time, put out a statement on interchangeability. The regulator teamed up with HMA to issue the joint statement.
“Interchangeability refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect. HMA and EMA consider that once a biosimilar is approved in the EU it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product,” the agencies wrote.
The agencies presented the scientific rationale to support a statement that is intended “to reduce any uncertainty that prescribers may have when deciding to prescribe biological medicines.” In the scientific section of the statement, the agencies explain that “switching between biological medicinal products manufactured and commercialized by different companies has become common in clinical practice, and interchangeability of EU-licensed biosimilars has been confirmed.”
However, while the statement clarifies the situation regarding interchangeability, by necessity it leaves the question of substitution up to member states. EMA opted against offering a view on substitution, which can be done at the prescriber of pharmacy level, because the topic is outside of its remit. Even so, the statement was welcomed by the off-patent medicines industry.
“We appreciate the strong statement from Europe’s medicine regulators for two reasons. First, it provides a clear and harmonized view across all member states. Second, it is unambiguous and backed by the wealth of European regulatory and clinical experience with biosimilar medicines. With the issue of biosimilar interchangeability now formally clarified, an important barrier to biosimilar medicines uptake has been solved,” Adrian van den Hoven, director general of Medicines for Europe, said.
EMA Notice, Joint Statement, More
Swissmedic harmonizes nitrosamine requirements with EMA, extending variation deadline
The Swiss Agency for Therapeutic Products (Swissmedic) has harmonized aspects of its approach to the potential for nitrosamine contamination with practices in the EU. Swissmedic committed to harmonize its requirements when possible last year but has only recently issued a response to events since then.
After Swissmedic published its position on nitrosamines in April 2021, EMA continued to release tweaks to its own requirements. Swissmedic intends to harmonize its requirements with the EU “as far as this is scientifically reasonable and is possible within the provisions of Swiss therapeutic products legislation,” but the absence of a statement on EMA’s changes since April 2021 left questions about the Swiss rules.
Now, Swissmedic has clarified the situation with an update that addresses the changes EMA has made over the past 17 months. The Swissmedic update confirms that Switzerland will follow the EU in delaying the deadline for submitting changes to the marketing authorizations of chemically synthesized medicines until 1 October 2023. EMA delayed the deadline by 12 months in July.
Swissmedic also responded to EMA’s update to the risk factors for finished products. In its response, the Swiss regulator called for manufacturers to take into account the potential for N-nitroso derivatives of the active substance to form in finished products with traces of nitrosylating substance contamination. If needed, companies should mitigate the risk with analytical testing. Swissmedic recommends nitrocellulose-free blister components for packaging materials.
Elsewhere in its response, Swissmedic refers to EMA’s clarification that the Ames test “forms part of a comprehensive, evidence-based assessment and is not sufficient as a sole criterion for classification as a Class 5 impurity according to ICH M7,” and adopts both the EU’s acceptable intake figures and the basic approach for determining them.
Swissmedic Notice
MHRA clarifies rules on advertising of drugs supplied by alternative Northern Irish route
The Medicines and Healthcare products Regulatory Agency (MHRA) has added a section in advertising and promotions to its guidance on the the Northern Ireland MHRA Authorised Route (NIMAR).
The UK government created NIMAR to ensure people in Northern Ireland, where EU regulations continue to apply after Brexit, can access prescription-only medicines if authorized products or any other existing regulatory routes are unable to meet clinical needs. In updating its guidance on the topic, MHRA has clarified the restrictions that apply on products supplied to Northern Ireland via the route.
“Marketing authorization holders should manage the supply of NIMAR products in a similar manner to medicines with a valid marketing authorisation for [Northern Ireland] in accordance with the specific rules that apply to NIMAR. However, as NIMAR listed medicines hold a [Great Britain] license, they should only be advertised (i.e. actively promoted) in England, Scotland and Wales,” the guidance states.
MHRA goes on to clarify that the restriction on promotion “does not preclude legitimate interactions and communications necessary to maintain medicines supply.” The agency expects marketing authorization holders to “take all reasonable precautions to ensure that advertisements do not appear in the territory where the medicine is not licensed.”
MHRA Guidance
MedTech Europe welcomes proposed changes to AI regulation to ensure human oversight
MedTech Europe has voiced support for a European Parliament’s committee’s opinion on the proposed harmonized rules for artificial intelligence in the EU, hailing its recognition of the need for context-based human oversight of technology.
The trade group outlined concerns with the original proposal for an Artificial Intelligence Act last year. Last week, the Committee on Legal Affairs (JURI) offered its opinion on the proposal as part of the parliamentary review of the plan. MedTech Europe welcomed JURI’s publication, particularly its stance on the role humans need to play in the deployment of AI-based systems.
“The amendments provide a right step toward context-based human oversight, with effective consideration regarding the particular risk of the AI system in question and its level of automation. For AI-embedded medical technologies, such AI systems traditionally provide assistance and support by, for example. providing more accurate recommendations and leave the final say to the licensed healthcare professional, charged with the patient’s care, before any action is taken,” the trade group wrote.
However, MedTech Europe also praises JURI for seeing that sometimes people may need to get out of the way of technology, noting that in certain circumstances “human intervention can negatively impact the functioning of AI-embedded medical technology, affecting the patient’s well-being.”
Press Release, JURI Amendments
Other news:
Ireland’s Health Products Regulatory Authority (HPRA) has published a document on potential conflicts of interest for its patient forum. The guide outlines the conflicts that participants need to declare. HPRA Guide

© 2022 Regulatory Affairs Professionals Society.

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