Asia-Pacific Roundup: India’s CDSCO seeks feedback on revised biosimilar authorization guidelines
India’s Central Drugs Standard Control Organization (CDSCO) has released draft revisions to guidance on biosimilar marketing authorization requirements for consultation.CDSCO published its original biosimilar guidelines in 2012. The agency updated the document in 2016 to emphasize scientific principles and a stepwise approach to demonstrating similarity between biosimilars and reference products. CDSCO said the latest proposed revisions reflect the current international guidelines, primarily guidance published in 2023 by the World Health Organization.
“Since major countries are moving for waiver of non-clinical studies for similar biologics, the current revision principally focuses on strengthened orthogonal analytical tools and in vitro studies to establish similarity between the similar biologic product and reference biological product,” CDSCO said.
Key changes in the draft guidance include the introduction of scientific considerations and key principles for licensing biosimilars, according to CDSCO. The agency has proposed adding two sections covering the considerations and principles.
In the all-new key principle section, CDSCO said the characterization of the reference product’s quality attributes should be the first step in guiding biosimilar development. Subsequent steps should show the structural, functional, and clinical similarity of the two molecules.
CDSCO said structural and functional similarity is a prerequisite, and a “tailored clinical data package” can be required as needed. Comparative human trials assessing pharmacokinetics, pharmacodynamics, and immunogenicity “will typically be a core part of the clinical comparability assessment, unless scientifically justified,” the agency said.
“The decision to license a similar biologic should be based on evaluation of the whole data package generated during the overall comparability exercise,” CDSCO said. “If relevant differences between the proposed similar biologic and the [reference product] are found at the structural, functional, or clinical level, the product is unlikely to qualify as a similar biologic.”
Almost all the text in CDSCO’s scientific considerations section is new, too. The new section covers some of the same points as the key principles and provides additional details, such as the need for companies to “demonstrate a thorough understanding of their product, ensure consistent and reliable manufacturing processes and provide a comprehensive quality dossier.”
CDSCO has proposed changes to sections on quality, nonclinical, and clinical evaluation to make them clearer and more flexible while aligning with current international practices. Specific changes include the introduction of next-generation analytical methods for showing similarity, advice on the use of reference standards, new statistical guidance, and information on minimizing the use of animals in testing.
“If the quality comparability exercise and the nonclinical in vitro studies have shown high similarity and the level of residual uncertainty is considered acceptable to move to the clinical phase of the similarity exercise then an additional in vivo animal study is not considered necessary,” CDSCO said.
The agency updated its flow chart to set out when companies can apply for a preclinical study waiver. The chart shows how changes to animal testing and other aspects of development will affect the steps involved in bringing biosimilars to market in India.
CDSCO, which published the draft on 6 May, is accepting feedback for 30 days.
CDSCO Notice
CDSCO shares guidance on no-objection certificates for exporting new drugs
CDSCO has shared guidance for companies that want to obtain no-objection certificates to export unapproved or approved drugs from zonal offices.
Applying for the certificate is an online, two-step process, according to the guidance. The first step is to register with the zonal office. Companies must complete the integrated registration form online and provide a copy of the manufacturing license.
CDSCO is also requesting an approval document from the regulator in the importing country. If that document is not available, CDSCO may accept its own approval documents for active pharmaceutical ingredients (APIs) and finished products. Manufacturers of APIs and finished products that are not approved in India can submit authorization documents from a stringent regulatory authority.
Specific requirements apply to narcotic drugs and psychotropic substances; fixed-dose combinations that are not approved in India; and medicines that are banned in India. Approval paperwork from the regulator in the importing country is mandatory for those products. CDSCO banned two opioids earlier this year after media reports that an Indian company was exporting an unapproved combination.
The certificates issued by zonal offices last one year. Companies that receive a certificate can advance to the second step. At that stage, exporters need to provide information such as the certificate of analysis for the batch and a purchase order, export invoice, or shipping bill with details of the transaction.
CDSCO Guidance
Medsafe posts statement on early supply issue notifications in New Zealand
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published a statement on early notification of potential drug supply issues.
Medsafe issued the joint statement with the Pharmaceutical Management Agency (Pharmac), a body that decides which medicines receive government funding in New Zealand. Toward the end of 2024, Pharmac noticed an increase in late notifications of supply issues alongside requests to support priority applications to Medsafe.
“To help ensure a reliable supply of medicine for patients, we encourage sponsors to reach out to your Pharmac Contract Manager as soon as you foresee any supply challenges or potential issue arises. Early communication makes it easier for Pharmac to explore options and find solutions with companies,” the organizations said in the joint statement.
Medsafe does consider priority applications with Pharmac’s support, the agencies said, but the number of applications that can be prioritized at any given time is limited. Prioritizing applications can affect the processing time of other pending submissions.
Sponsors that anticipate a supply issue that may require regulatory action should contact Medsafe as early as possible and provide information about the disruption. The agencies said, “Ensuring consistent information is shared with both Medsafe and Pharmac helps streamline the process.”
Medsafe Statement
Otsuka gets higher price after appealing to NPPA about packaging features
India’s National Pharmaceutical Pricing Authority (NPPA) has raised the price cap on three formulations from Otsuka after hearing an appeal that focused on the benefits of packaging features.
NPPA’s Multidisciplinary Committee of Experts has discussed the price of Otsuka products that contain potassium chloride, dextrose monohydrate and sodium chloride multiple times over the past year. In August, the committee recommended a price of as little as Rs 33.81 ($0.40) per pack. The claimed price was Rs 284.83.
Otsuka appealed, and the committee assessed more evidence across a series of meetings. In December, the committee said Otsuka showed it special features of the product packaging such as “self-sealability, self-collapsibility, no air vent requirement and no chances of contamination during manufacture, infusion and admixing level.”
NPPA published prices last week based on the committee’s assessment of the evidence. The product that originally received a recommended price of Rs 33.81 can now sell for Rs 75.67. NPAA set higher prices for two other formulations, topping out at Rs 151.89 for a combination that contains more ingredients and has different packaging than the other products.
NPPA Notice
Other news
Singapore’s Health Sciences Authority (HSA) is overseeing a Class 1 recall of a glucose support product that was found to contain glibenclamide and metformin. HSA Notice
×
Welcome to the new RAPS Digital Experience
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.
We welcome your feedback. Please let us know how we can continue to improve your experience.