November 11, 2022 Pharma Regulatory Updates
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BioPharma – USA/Europe/Asia Regulatory Updates, Week 1 Nov 2022

Europe (EU)

MHRA updates biosimilar guidance to allow interchangeability between products

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use the same reference medicinal product (RP). On 6 November, the British regulatory agency updated a 2021 document titled Guidance on the licensing of biosimilar products. It has expanded the interchangeability section of the document to account for biosimilars that have the same RP. “Once authorized, a biosimilar product is considered to be interchangeable with their RP, which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect,” according to the guidance. “Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.

EMA Guidance Sets Out Criteria, Process for Requesting Orphan Drug Designation

Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the rare disease, the scope of the application, the drug’s active substance and mode of action and supporting clinical and nonclinical data.

EMA Recommends Minimizing JAK Inhibitor Use for Some Patients

Older people, smokers and those with an increased risk of cardiovascular problems shouldn’t use Janus kinase inhibitors for chronic inflammatory diseases unless there are no other suitable treatment options, according to new recommendations by the European Medicines Agency (EMA).

USA

FDA officials discuss biosimilar inspections, BsUFA enhancements

A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as these products are relatively new and involve novel manufacturing processes. She also noted that the facilities making these products are generally new to biosimilar manufacturing. Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation and Research (CDER), made the remarks at the Association for Accessible Medicines’ (AAM) GRx+Biosim conference in Bethesda, MD on Monday.

High concordance in breakthrough therapy, PRIME decisions

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) agreed on nearly two-thirds of decisions to grant or deny requests for drugs and biologics seeking Breakthrough therapy or Priority Medicines designation, according to a new analysis.
The findings highlight the need for agencies and sponsors to take advantage of collaborative opportunities, including the Parallel Scientific Advice program, to support global drug development that addresses unmet medical needs, wrote Zahra Hanaizi, of the EMA, along with colleagues at EMA and FDA, wrote in Therapeutic Innovation & Regulatory Science.

FDA combination products chief eyes new guidances next quarter

The Office of Combination Products (OCP) at the US Food and Drug Administration (FDA) has seven priority guidances in development, which OCP Director Thinh Nguyen hopes will be published in the first quarter of 2023.

FDA Places Hold on Verve’s IND for Gene-Editing Candidate

The FDA has placed a hold on Verve Therapeutics’ Investigational New Drug (IND) application to conduct a clinical trial evaluating the company’s VERVE-101 gene editing treatment to inactivate a specific gene in the liver and reduce low-density lipoprotein cholesterol. The therapy candidate is targeted to treat patients with heterozygous familial hypercholesterolemia, an inherited genetic disorder that causes hardening of the arteries.

FDA’s expedited programs play increasing role in bringing novel drugs to market

Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan products using expedited programs alone in combination to achieve FDA approval more frequently over the last 13 years, according to recent research published in JAMA Network Open.

FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded access should be implemented given new regulatory access and statutory requirements through the 21st Century Cures Act (Cures Act) and FDA Reauthorization Act of 2017 (FDARA).

FDA finalizes umbrella trial guidance for cell and gene therapies

The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in a clinical trial for a single disease. The agency said its final guidance should help sponsors conduct umbrella trials of similar products for the same disease more efficiently to bring cell and gene therapies to market sooner.

FDA Finalizes Guidance on Cross-Labeling of Combination Oncology Drugs

Sponsors should be prepared to discuss proposed labeling for combination oncology drug regimens with the FDA in pre-application meetings, the agency said in a final guidance released yesterday.

FDA Cites Sovereign Pharmaceuticals for Multiple Quality Control Problems

Sovereign Pharmaceuticals, a contract development and manufacturing organization (CDMO) based in Fort Worth, Texas, has received an FDA warning letter citing multiple quality control issues that led to inconsistent tablet weights.

AdComm Approves of FDA Plans to Further Develop and Expand KASA Program

An FDA advisory committee voted 13-0 yesterday in favor of the agency’s long-term strategy for its Knowledge-Aided Assessment and Structured Application (KASA) program, including expanding it from just generic drugs to new drugs and biologics assessments over the next five years.

FDA Releases Digital Health Research Priorities

The Center for Devices and Radiological Health (CDRH) is encouraging research on the use of digital health technologies (DHT) to advance patient engagement, leverage connectivity and improve healthcare, according to a report the center released last week.

Asia

MSF accuses UK of ‘seeking to gut India’s patent and drug regulatory laws’

Médecins Sans Frontières (MSF) has accused the UK of trying to remove safeguards from India’s patent and drug regulatory laws that make the Asian country “a manufacturing powerhouse.” MSF made the statement after reviewing a leaked copy of a section of a draft free trade agreement (FTA). The leaked intellectual property chapter of the proposed FTA discusses topics including patents, stating that each country should provide pharma companies with “an adequate and effective mechanism to compensate the patent owner for the reduction in the effective patent term resulting” from the marketing authorization process.

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