Regulatory Focus™ > News Articles > European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

Posted 11 January 2018 | By Nick Paul Taylor 

European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

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

Swissmedic Updates Biosimilar Guidance to Allow Comparators of US Origin

The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States.

That marks a change in the policy Swissmedic established when it formally adopted biosimilar rules last year. At that point, Swissmedic only permitted the use of comparators from the European Union or Switzerland in the main studies of biosimilars. The updated guidance adds the US to the list, but companies that opt to source comparators from across the Atlantic will face additional regulatory requirements.

“If the product is obtained from the USA for the comprehensive comparability studies with the biosimilar – including safety and efficacy – three-way bridging between the biosimilar, the EU and the US comparator product must be carried out,” Swissmedic wrote in its updated guidance. Companies that work with EU comparators only need to perform bridging with the Swiss reference product.

Swissmedic also used the update to liberalize its rules on the origins of drugs used in complementary biosimilar studies. The changes see Canada join Japan on the list of countries that can supply products for use in these trials. Regardless of whether the product comes from Canada or Japan, Swissmedic expects the company to compare them to the EU product. Direct bridging to the reference product is not needed.

The final notable change to the guidance sees Swissmedic follow the European Medicines Agency (EMA) in requiring the inclusion of an environmental risk assessment (ERA) in filings for approval of biosimilars. Companies can skirt the ERA requirement if they provide an appropriate reason.

Swissmedic Statement, Biosimilar Q&A

EMA Shares Advice on in-use Shelf Life of Drugs in Multi-Dose Containers

EMA has added sections on multi-dose containers to its quality of medicines question and answer document. The new sections cover the design of and claims for in-use shelf life for solid oral dosage forms in multi-dose containers.

The design section clarifies that companies need to run in-use stability studies on tablets, capsules and other solid oral dosage forms in multi-dose containers if, “There is an indication from stability and/or stress studies that the drug product may be susceptible to deterioration.” If there is such an indication, EMA expects companies to run stability studies under long-term conditions.

The exact length of the study will depend on the intended use of the drug. If patients will only need one multi-dose container for the duration of the treatment, the manufacturer should run studies that are at least as long as they will be on the drug. For drugs that are only used intermittently, EMA expects companies to assess whether in-use stability fails within six months. If not, no in-use shelf life is needed.

When assessing the stability of intermittently needed drugs, manufacturers should incorporate less than daily opening of the container into their designs. This mimics the likely frequency with which patients will open the container and, therefore, affect the stability of the solid oral dosage forms it contains.

Alternatively, companies can perform open-dish stability studies. These studies assess the stability of products without the protection of the immediate container. This should result in conditions that are more likely to lead to instability than those the drug will face in the real world. If the product remains stable for three months in these conditions, EMA will waive the need for in-use shelf life.

EMA Q&A

EMA Starts Posting Jobs on Vacancies Portal, Creates Guidance for Users

EMA has begun posting vacancies at the Jobs@EMA portal. The agency marked the establishment of the portal with the creation of a guide for users who want to use it to keep track of and apply for job openings.

People can use the portal to search by keyword for jobs and filter by how recently the job was listed, or simply see all the jobs that are available at EMA at a given time. Users can sign up to get alerts whenever a job matching their search is posted.

The more advanced features, and the reason EMA has released a guide to the portal, relate to the use of the platform to apply for jobs. Users can create profiles that cover information such as their work experiences and the languages they speak. When the user sees a job they are interested in, they can use their profile to apply.

Users can then track the status of their applications in another part of the portal. This section shows the status all the applications made by the user. If EMA offers the user a job, the role is shown in the “my offers” section.

The revisions to the process of applying for a job at EMA come at a time when the agency is facing the prospect of having to hire staff relatively heavily and quickly to offset losses triggered by its move from London to Amsterdam.

Jobs Portal, EMA Guidance

Swissmedic Stops Accepting Email Orders for Certificates of Pharmaceutical Product

Swissmedic has stopped accepting orders for Certificates of Pharmaceutical Product (CPP) via email. The agency changed its policies so companies can only request the certificates through the eGov portal this week.

Swiss officials detailed plans to establish an online portal for filings related to clinical trials, exemptions for non-conforming medical devices and export certificates last summer. Those vague plans coalesced into a commitment to switch from an email to portal-based process for CPPs early in 2018. The deadline for the switch was 8 January. 

Having passed that milestone in the rollout of the portal, attention will now turn to how the portal fares in the real world and the expansion of its use to cover other regulatory submissions.

Swissmedic Notice

Finland Starts Investigation Into Factors That Influence Biosimilar Uptake

The Finnish Medicines Agency (Fimea) has begun an investigation into factors that encourage and deter the adoption of biosimilars. Generating insights into the drivers of biosimilar penetration could help Finland bring down healthcare costs.

Fimea is focusing its investigation on rheumatic diseases, inflammatory bowel diseases, psoriasis and diabetes. That list covers diseases targeted by some of the biosimilars with the most potential to cut healthcare costs by taking market share from costly and widely used innovative biologics, such as Humira and Remicade.

The study will assess the treatment of diseases in those therapeutic areas at hospitals across Finland.

Fimea expects to generate the first results from the study next year. The results will inform policy decisions in the country.

Fimea Statement (Finnish)

Other News:

The United Kingdom has sent a notice to Astrids Oil & Product regarding a product sold by the firm. Officials in the UK found the product was not authorized in line with regulations on veterinary medicines. As such, they have sent a notice telling the company to remove certain medicinal claims from its website. Government Statement


Categories: Regulatory News

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