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Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
December 14, 2025
Approximately 5 minutes
Handling of Non-proprietary Names and Brand Names related to Biosimilars in Japan
Document overview
Japan’s Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Food Safety Bureau (Evaluation and Licensing Division), issued PFSB/ELD Notification No. 0214-1 on February 14, 2013: Handling of Non-proprietary Names and Brand Names related to Biosimilars. The notice revises and replaces an older notification (dated March 4, 2009) to better clarify handling, especially for simple protein drugs, and states the old notification will be abolished upon implementation of the new one. Reference: PMDA PDF.
Regulatory intent: “distinguishable at a glance”
The central requirement is that both the non-proprietary name and the brand name of a biosimilar must be easily distinguishable from:
- the original biopharmaceutical, and
- other biosimilars, so it is clear the product is a biosimilar. Reference: PMDA PDF.
Non-proprietary name rule (generic name)
Default approach: originator’s non-proprietary name + bracketed “biosimilar” numbering
The notice explains that the non-proprietary name should be determined in accordance with relevant naming notifications, and then “biosimilar 1 (2, 3, …)” is added in square brackets to the end of the originator’s non-proprietary name excluding the “genetical recombination” descriptor, at the point the product is determined to be a biosimilar through the individual approval review. Reference: PMDA PDF.
Special case: simple protein drugs with the same primary structure
For products where the primary structure of the intended active ingredient of a simple protein drug is judged to be the same as that of the originator’s active ingredient, the notice states the non-proprietary name should be the same as the originator’s, without adding a new non-proprietary name. Reference: PMDA PDF.
Brand name rule
For the brand name, the notice indicates it should, in principle, follow the brand-name handling notification referenced in the document, where:
- dosage form, content/strength, and company name (house name, etc.) are appended to the non-proprietary name, and
- the “genetical recombination” descriptor is omitted from the name, and
- “BS” is attached instead of the bracketed “biosimilar 1 (2, 3, …)” expression used for the non-proprietary name. Reference: PMDA PDF.
Example shown in the notice (illustrative placeholders)
- Non-proprietary name (example format):
○○○○○ (Genetical Recombination) [××××× biosimilar 1] - Brand name (example format):
××××× BS Injection Content Company name(Where ××××× denotes the originator’s non-proprietary name excluding “(genetical recombination)”.) Reference: PMDA PDF.
Practical takeaways for sponsors and reviewers
- Plan naming early: numbering (“biosimilar 1/2/3…”) is tied to approval review outcomes, so align regulatory and labeling teams early.
- Use naming to support pharmacovigilance: distinguishable names can reduce medication errors and help traceability in real-world use.
- Watch the simple-protein exception: when primary structure is judged the same, the generic name approach differs, so confirm applicability during consultations. Reference: PMDA PDF.
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