The US Food and Drug Administration and European Medicines Agency often take the spotlight when it comes to regulatory submissions. While, indeed, these are the two major markets for drug developers, beyond them is a whole untapped world – emerging markets. But why should one care about these markets?
“Emerging markets comprise 85% of the global population and offer vast opportunities for drug development due to rising lifestyle diseases and increased healthcare spending,” explained IQVIA’s associate director of regulatory affairs Ankit Tyagi during a recent webinar, titled “Expanding Horizons: Regulatory Strategies for Biosimilars and Generics for Global Success.”
During the event, various experts, both from IQVIA and the industry, shared best practices when it comes to global regulatory submissions, especially in emerging markets.
Tyagi highlighted that consortiums and partnerships between developed and emerging markets add a layer of opportunities, such as Project Orbis or ACCESS Consortium. But there are also commercial considerations that generics and biosimilars developers should know when entering these smaller markets.
One of them is understanding the local reimbursement strategy. In some countries, such as Turkey, Russia, Indonesia, and Algeria, manufacturing, either a portion or all of it, needs to be completed locally in order for products to be eligible for public reimbursement, Tyagi explained.
Labeling strategy is also a key aspect. Depending on the disease prevalence, a generics and biosimilars company may register fewer indications than in the reference country to suit specific market needs and reduce the pharmacovigilance burden.
Knowing clinical trial requirements is also crucial. For example, agencies in China, Taiwan, and Korea may not require additional clinical trials, if an innovator product has sufficient foreign clinical data demonstrating safety, and efficacy, and shows no ethnic sensitivity.
However, Tyagi stressed the “may” part, as relevant bridging clinical studies may still be required if ethnic sensitivity data is lacking.
When it comes to approval pathways, choosing the wrong one may cost time. Taking Singapore’s Health Sciences Authority as an example, the agency has three options that all have different timeframes: full registration takes up to 270 days; an abridged pathway, meaning one reference agency already approved the product, could take 180 days; while the verification route, when the drug is approved by two reference agencies, only takes 60 days.
“When you are preparing your regulatory strategy for the emerging market, first decide what is the right pathway, because time difference can vary a lot from the submission to the approval,” Tyagi said.
Finally, there are certain formulation considerations that need careful assessment. In the Middle East, a drug manufacturer must provide an appropriate declaration proving that all ingredients are porcine- and alcohol-free.
Solutions To Streamline Global Submissions
A strong regulatory intelligence is crucial to ease the submission process, especially given that these emerging markets are “going through a steep adoption curve, aligning to the regulated markets and the guidelines are ever-changing,” said Amar Tandon, an associate director of regulatory affairs at IQVIA.
Also, having local partners in place is as equally important as they can “have regular communication with health authorities, understand the latest requirements and the trends being followed, and make sure that we take equal and required action for the quick approval processes in those regions,” he added.
Pfizer’s director of brand CMC global regulatory strategy, Padmanaban Ganapathia Pillay, shared during the panel session tips on best practices for timely submissions. One of them is having well-planned milestones that are based on internal or in-house metrics, as the same timelines may not work for every company.
Pillay also explained that having a cross-functional team and understanding their contributory lines, competencies, and expertise is a critical element, and “having that in place will help in terms of arriving at a great regulatory submission.”
Throughout the webinar, there was one recurring suggestion to streamline the regulatory process in emerging markets: a core dossier, which is prepared in such a way that it can be changed according to local requirements.
“We should have a core dossier, which caters to all the formats, and then, based on the needs, we can tailor it into the formats of that particular country,” explained Lupin Biotech’s global regulatory affairs lead Praveen Reddy.
Technology and digital tools were also discussed as ways to enhance the efficiency of dossier submissions. Rama Mohan Rao Chikkam, IQVIA’s senior director of regulatory affairs, said that AI-based tools, “which is a real buzzword in this industry today,” can automate repetitive tasks such as data entry and document formatting, which could save time and reduce the risk of human error.
