A biosimilar medicine is a biological medicine, derived from a biological source and based on naturally occurring proteins in the human body. They are produced using living cells including bacteria and yeast.
Biosimilars have been shown not to have any clinically meaningful differences from the originator’s approved biological medicine in terms of quality, safety and efficacy. However biosimilar medicines are not considered generic equivalents to their originator biological medicine because the two products are similar but not identical. Biosimilars will have met regulatory requirements in terms of comparative quality, safety and efficacy.
Development of biological medicines, including biosimilar medicines, creates increased choice for patients and clinicians alike, increases commercial competition and innovation and enhances value propositions for individual medicines. This is significant in terms of budget constraints and value based decisions.
In the highly regulated markets of UK, EU, US, Canada, Japan and Australia, Clinical trials are regarded as a prerequisite to any biosimilar approval.
As an experienced Clinical Trials (CT) supplier, Smartway Clinical Trials Supply (CTS) will:
- Assure a rapid and an accurate response to your inquiry
- Offer complete confidentiality to our customers
- Thoroughly evaluate the market for the availability of the product
- Anticipate challenges and plan ahead with due diligence
- Take into consideration lead times
- Ascertain manufacturer’s restrictions
- Establish secondary market availability
- Confirm costs and expiration dates of products
- Provide documentation and relevant product information
- Offer a safe and a cost-effective shipment solution under cold chain and ambient temperature to the Clinical Trial site.
With our extensive and established links to authorised suppliers and manufacturers, our customers can rely upon us and have complete confidence in the safety and quality of the products we supply, not only cost-effectively but in medically-appropriate quantities and within a specified time-frame.
We believe that those with a smart sourcing strategy, like Smartway CTS, will be integral to your success within the clinical trials arena.