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What are BiosimilarsManufacturing BiosimilarsPfizer's Heritage & ExpertiseOncology Biosimilar Portfolio

Prescribing information for relevant Pfizer oncology biosimilars and Adverse Event reporting information can be found at the bottom of the page. 
Manufacturing Biosimilars

Manufacturing biologics and biosimilars is more challenging than producing a generic equivalent of a patented small-molecule drug. The added complexity of manufacturing stems from:1 
 

  • Their large size and complex structure
  • Being derived from a living biological system 
  • Difficulty in fully defining their characteristics
 

Significant expertise and investment are required to ensure that it is ‘highly similar’ to the reference biologic product with no clinically meaningful differences in the safety profile, efficacy, potency or quality.1,2 This means extensively identifying and comparing the structural and functional properties of the biosimilar, using state-of-the-art technology.²

Comparative structural and functional characterisation provides foundational information about the clinical predictability of biosimilars.³

Stages of Production

The manufacture of biologics and biosimilars is a complex, multistep process.1,2,4 Refer to the image below to see the key steps in biosimilars production.5
 

 Biologics Approval

Biosimilar medicines are manufactured according to the latest state-of-art-technology, ensuring the highest quality standards available.2,4

Pfizer’s biosimilars have undergone testing and refinement to meet stringent licensing requirements. 

This includes: 
 

  • Developing an equivalent host-cell clone & preparing cell banks (this can take up to 1-1.5 years)4
  • Process development, fermentation, purification & manufacturing scale-up (this can take up to 1-1.5 years)4

Only when these meet the required standards can the comparability testing, analytical characterisation, non-clinical studies, and clinical studies be undertaken. These can take between 3.5 and 4.5 years to complete.4

Unlike generic drugs, biosimilars are not licensed purely on the results of pharmaceutical and bioequivalence studies. As well as demonstrating comparable efficacy and safety to their respective reference biologics, biosimilars must show that they are of the same equivalent quality as their reference products. Quality in this context refers to the controls and standards for all aspects of manufacturing, preparation and processing.2,4

The Pillars of Biosimilar Product Development and Marketing Approval4

 



Prescribing Information for Great Britain and Northern Ireland:

 

Trazimera® (trastuzumab) Nivestim® (filgrastim)
Ruxience®▼ (rituximab) Retacrit® (epoetin zeta)
Zirabev®▼ (bevacizumab)  
References:​​​​​​​
1.  Association of the British Pharmaceutical Industry (ABPI). Biological and biosimilar medicines in the UK. Available from: https://www.abpi.org.uk/media/edofq4m0/biological_biosimilar_medicine_uk.pdf Published July 2014. [Accessed October 2022]. 
2.  Medicines and Healthcare Products Regulatory Agency. Guidance on the licensing of biosimilar products. Available from: https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products Published May 2021. [Accessed October 2022] 
3.  Webster CJ, et al. An Efficient Development Paradigm for Biosimilars. BioDrugs. 2019;33(6):603-611. 
4.  Medicines for Europe (formerly EGA) Biosimilar Medicines Handbook. 2016.
https://www.medicinesforeurope.com/2016/04/25/biosimilar-medicines-handbook-new-edition/ [Accessed October 2022].
5.  Sekhon BS and Saluja V. Biosimilars 2011;1:1-11 
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