Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an English-language version of its updated advice on quality, safety and efficacy of biosimilars.

PMDA released a question-and-answer document on its guideline for ensuring the quality, safety and efficacy of biosimilars four years ago, and updated it earlier this year. In a new English-language translation of the update, PMDA explained that it made changes to the text “based on scientific knowledge at the present time.”

The updated Q&A features significant changes to question 10, which now asks “is it acceptable to use data from clinical trials conducted in non-Japanese subjects that confirm the equivalence of [pharmacokinetics] and efficacy (including [pharmacodynamics]) with original biopharmaceuticals for approval application?”

In its response, PMDA explained that biosimilar trials are intended to confirm the bioequivalence of pharmacokinetics (PK) and efficacy including pharmacodynamics (PD). As such, data from overseas trials in non-Japanese participants may be used “if the ethnic factors of subjects do not affect the study results,” PMDA said. If ethnic factors do affect the study results, the methods set out in the Basic Principles on Global Clinical Trials guidance “cannot be directly applied to the number of Japanese,” the agency added.

“The plan should be such that it can be explained that there is no discrepancy between the results of the Japanese population and those of the overall population with reference to the above notification,” the agency wrote.

PMDA added a new question to explain how to assess if ethnic factors are expected to affect clinical trial results. The agency said, “it is possible to identify ethnic factors and their impact based on the original biopharmaceuticals and to confirm the results of Japanese subgroup analysis of clinical trials from currently available evidence of original biopharmaceuticals.”

The regulator went on to add that “if some differences of quality attribute between a biosimilar and the original biopharmaceutical was observed, it is important to evaluate ethnic factors and their impact focusing on the differences.”

PMDA Guideline

Philippine FDA sets 30 September as enforcement date for medical device rules

The Philippine Food and Drug Administration (FDA) has finalized a further extension to the deadline for obtaining a Certificate of Medical Device Notification for previously non-registrable Class B, C, and D medical devices.

FDA sought feedback on plans to delay the deadline until 30 September 2024 earlier this year. The plan is going ahead now FDA has closed the consultation, marking the third time that the agency has given the industry more time to comply. FDA set a March 2022 deadline when it first finalized its plan in 2021 and then extended the timeline in April 2022 and March 2023 to avoid disruptions to supply.

The agency shared details of the third extension alongside updates on its guidelines for licensing retailers of medical devices in the Philippines. FDA published an order to simplify the application process in 2020. The order took effect in December 2021 and had a two-year transition period.

Last week, FDA extended the transition period “until the migration of the online licensing application process from the ePortal System to the eServices Portal System has been completed for the said establishments.”

FDA added that licensed traders or distributors that sell or intend to sell directly to the general public have until 30 June 2024 to secure the approval of a variation to their licenses. After that, the agency will ban companies that lack an amended license from selling medical devices directly to the public.

FDA Notice

TGA tests show ‘compounded’ semaglutide linked to hospitalization is substandard

Australia’s Therapeutic Goods Administration (TGA) has found vials of the GLP-1 drug semaglutide that purported to be compounded were substandard and contained the wrong amounts of two ingredients.

TGA tested the vials after a subcutaneous injection of the compounded semaglutide-like product was alleged to have hospitalized a patient with peripheral neuropathy. The product was supplied to patients via regular mail and was not purchased and dispensed from an Australian pharmacy.

The label said the vials contained 100mg/mL of L-carnitine and 0.05mg/mL of B12. However, TGA’s tests found the vials contained ten times more B12 than the label claimed and significantly less L-carnitine, 0.5 to 0.7mg/mL. TGA also observed that the product “had solution within blue capped vials which was a distinctive red color which is not the expected appearance.”

Officials are yet to determine where the product was manufactured. TGA used the notice to warn the public that “the compounding of semaglutide-like products by individuals who hold no formal qualifications and in unsterile environments poses a serious risk to human health.” The agency is advising consumers not to use compounded semaglutide offered or issued without a prescription.

Semaglutide, which Novo Nordisk sells as Ozempic and Wegovy, is in short supply in Australia. Eli Lilly expects supplies of its rival GLP-1 diabetes drug, Mounjaro (tirzepatide), to be limited until September. Compounding pharmacies have moved to meet demand for the products but TGA has raised concerns about the safety of the medicines.

TGA Notice

TGA starts second phase of recall reforms to reduce regulatory burdens on sponsors

TGA has begun implementing the second phase of reforms to the recall process. The actions are informed by the public consultation that the agency carried out last year.

After reviewing the responses, TGA made changes to the Uniform Recall Procedure for Therapeutic Goods, reducing the number of recall progress reports from three to two, introducing more flexible reporting requirements for sponsor submissions of the two reports and otherwise trying to make the process less burdensome for industry. The consultation revealed a desire to limit unnecessary steps.

TGA has also reduced the number of steps in the recall procedure from 11 to 10, expanded the “Early Advice Notice” process to include stakeholders such as patient support groups and health professional guilds, and provided new guidance on the ‘lead regulator’ role in recalls of therapeutic products that are also consumer goods.

“Our reform work continues. One of the most endorsed proposals from our consultation paper was the new recall terminology. We will implement this when several supporting IT infrastructure changes are made to our systems,” TGA wrote.

TGA Notice

Malaysia’s MDA accelerates assessment of device establishment license applications

Malaysia’s Medical Device Authority (MDA) has shortened the medical device establishment license application assessment process to 14 to 21 working days. The clock starts on the day the evaluation officer receives the application.

During the evaluation process, MDA reviews an updated letter of authorization and list of medical devices, as well as documents related to the Person Responsible and the quality management system (QMS). The documents include a QMS report prepared by a registered conformity assessment body.

MDA will return submissions that lack some of the required materials and give the applicant 30 working days to provide the missing documents. The agency will reject the application if the establishment fails to provide the requested information by the deadline. This will not affect the right of the applicant to make a new application, and the application fee is not refundable, MDA said.

The agency framed the new timeline as part of its commitment to “enhancing the efficiency and speed of the establishment license application assessment process.”

MDA Notice

Asia-Pacific Roundup: Japan’s PMDA translates updated biosimilars guideline

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