IHS Global Insight Perspective | |
Significance | The HSA has released its guidance on biosimilar approval in Singapore, which has been mainly adapted from the EMEA regulation. |
Implications | Biosimilars such as vaccines and blood or plasma-derived products are not considered for approval at the moment. |
Outlook | The guidance is likely to open up the Singaporean market for biosimilar makers to expand the geographic penetration of their products. |
In the guidance, the HSA defined a similar biological/biosimilar product as "a biological medicinal product referring to an existing registered product, submitted for medicinal product registration by an independent applicant, and is subject to all applicable data protection periods and/or intellectual property rights for the original product".
The main stipulations in the HSA's biosimilar approval guidance include:
- An extensive comparability review is needed to establish similarity of a biosimilar to the reference product in terms of quality, safety and efficacy;
- The comparability assessment is to be applied to highly purified products, while biosimilars to products with more complex nature, such as vaccines, blood or plasma-derived products and their recombinant alternatives, and other types of biological medicinal products, including gene or cell products used for advanced therapy, and human tissues or cells intended for human application, will not be considered at the moment;
- The selected reference product for comparability studies must be a drug already registered in Singapore and a biosimilar can't be chosen as a reference product;
- The same reference product will be used for all three parts of the dossier (quality, safety and efficacy);
- Regulatory application is to be filed as a new drug application (NDA) via the abridged dossier evaluation route;
- In vitro studies and animal studies are required for the non-clinical review;
- The clinical comparability review will start with pharmacokinetic (PK) and pharmacodynamic (PD) studies followed by clinical efficacy and safety studies;
- In addition to current pharmacovigilance activities for all pharmaceutical products, other requirements such as reports on both serious and non-serious adverse drug reactions, periodic safety update reports and risk management plan;
- Biosimilars are also subject to a risk-based post-approval monitor.
In addition, the HSA also requests that the concerned biosimilar must be evaluated and approved by at least one of its reference agencies, namely, Australia's Therapeutic Goods Administration (TGA), Health Canada, EMEA and the U.S. FDA. Otherwise, the application is to be submitted with the complete dataset as per required for a new biological product.
The HSA's full guidance on biosimilars can be found here.
Outlook and Implications
Singapore's guidelines are largely in line with the EMEA version, including the current exclusion in considerations of products such as vaccine and blood/plasma-based biosimilars. By releasing the guideline on biosimilar approval, the HSA is joining other markets with similar moves such as Europe. In Asia Pacific, it follows Japan, which issued its guidance on biosimilar earlier this year (see Japan: 26 March 2009: MHLW Issues Guidelines on Biosimilars Development and Regulatory Applications) and granted its first ever approval for a biosimilar product to Sandoz's recombinant human growth hormone somatropin (see Japan - Germany - Switzerland: 25 June 2009: Sandoz Breaks New Ground as Japan Approves its Biosimilar Growth Hormone Omnitrope). For pharmaceutical companies, the implementation of the guideline is likely to open a new market for them to file the regulatory applications for their biosimilar products and bring them to the Singaporean market.