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How Biosimilar Manufacturers Can Get the Most Out of the "Patent Cliff"


As the number of biologics facing patent expiration in the US continues to rise, the market is further opening up to biosimilar manufacturers. George I'ons offers some pointers on how to secure an attractive market share during this time.

In coming years, the number of biologics facing patent expiration in the US is expected to continue rising, further opening the market to biosimilar manufacturers. Competition is likely to be very dynamic for certain treatments, hopefully lowering costs in the long run. While patients could be the biggest winners, with increased access to sometimes life-saving medications, deciding to switch over to a biosimilar product is not a given for everyone. Even with the attractive cost-benefit of transitioning, patients may be reticent to give-up a product they are already familiar with. Other non-financial factors will most certainly come into play, and biosimilar manufacturers will have to address as many of these decisive factors as possible if they are to encourage switching and successfully compete within this post-patent market. Amidst the trials and tribulations of securing uptake and confidence in biosimilars, biosimilars manufacturers are encouraged to draw from the following pointers below to secure an attractive market share during this opportune time. 

1.     Demonstrate well-tolerated and safe outcomes of switching

Firstly, biosimilar manufacturers will need to demonstrate the equal efficacy and safety of the medicinal component of their biosimilar product. Today, there is still some concern about whether or not all biosimilars are totally interchangeable with their respective original reference products. Although biosimilars are very similar in terms of their structure, biological activity and immunogenicity profile, the nature of their manufacturing process means that exact replication is not possible.1 As such, their active ingredients are not identical to the original product. With this in mind, physicians and patients alike will need some convincing and reassurance in the form of concrete evidence to support any decision to transition. This is gradually being provided by independent studies,2 thereby slowly alleviating some of these concerns, but there is still demand from regulators such as the FDA to get their hands on more supporting data. Drawing on the information already available to them, manufacturers should support their case for biosimilar adoption with real world evidence within their specific field-area.   

2.     Cultivate patient confidence in biosimilar delivery device

Beyond the overall confidence in biosimilars as a viable alternative to their original counterparts, there is a strong need for manufacturers to foster patient confidence in their specific product. This is particularly true during a time of a growing self-administration, where patients are increasingly carrying out their own subcutaneous injections and within their own home environment. These patients will be the first to want user-friendly and safe drug delivery devices. For instance, certain device designs and formulations may be more or less painful to inject – which makes a very good case for one particular product over another, particularly for a patient requiring frequent injections. Manufacturers are therefore advised to keep the patient firmly in mind when designing their products. Another significant consideration is compliance to sharp safety regulations. To break-down the specifics – safety devices for self-injection minimize the risk of needlestick injuries by staying clear of designs which retain an exposed needle after use3 and opting instead for auto-injector and pre-filled safety syringe designs. These require minimum usage steps and dexterity to use and ideally passive deployment of the safety mechanism. Such devices also minimise the risk of incorrect dosage and ensure complete medication delivery. Biosimilar manufacturers would therefore be wise to partner with a medical device company manufacturing safety syringes or to integrate human factors engineering if designing the device themselves. 

3.     Integrate Human Factors engineering

This leads us to the next point: human factors (HF) studies need to be carried out in order to assess and eliminate any user-based risks associated with the design of the device. These studies need to be carried-out in an all-encompassing manner. It will be fundamental to successful patient adherence that manufacturers are able to prove that they have examined and addressed these areas, and this may serve as a competitive distinguisher against other less meticulous businesses. 

Testing for cytotoxicity is a good first step towards ensuring the biocompatibility of a medical device, by firstly testing that the materials used in the delivery device are free of harmful extractables.4 Manufacturers will also need to factor in ISO10993 compliance for biocompatibility of materials for irritation and skin sensitization.

4.     Evaluate product manufacturability 

It would be detrimental to try to design a complex, innovative product if at the expense of long-term reliability or ease of controlled manufacture.5 Commentators6 have listed some considerations regarding the manufacturability of the device product, namely usability and robustness; assembly and manufacturing risk management; supply chain reliability; environment and disposal risks, as well as post-shipping device performance as part of the development process. Furthermore, encouraging post-production monitoring and feedback that goes beyond base compliance requirements can feedback into the design process. Manufacturers’ understanding of their end-users and ability to cater to their needs as part of the product design process will ultimately find this beneficial and it may in turn help gain more market share. 

5.     Consider regulatory requirements

Throughout the entire development process, manufacturers should keep a watchful eye on all matters relating to the regulatory compliance of their devices. With regulatory complexity and scrutiny never ceasing to grow, and with new standards on the horizon, allocating sufficient time and resources to ensuring total compliance is key to manufacturers achieving combination product approval. Lastly, allowing for a transparent and open development and design review process by compiling a complete design history file will be critical for both device manufacturer and also their biopharmaceutical partners. Not just from a regulatory perspective, but also with product-specific information which demonstrates a thorough analysis of all manufacturability and patient-centric considerations. 

To get their share of the market, biosimilar manufacturers are urged to take note of these 5 areas of consideration in order to optimize their drug delivery design and take on a greater portion of market shares against their original counterparts, as well as against other biosimilar manufacturers competing for this space.  

George I’ons is Head of Product Strategy and Insights, Owen Mumford Pharmaceutical Services.


1.     Lexocology, Biosimilars and patents, June 25, 2019: https://www.lexology.com/library/detail.aspx?g=215a4d2d-3f26-4f9e-a19c-4cfc77bec851

2.     Such as American College of Rheumatology, Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway, Oct 22, 2016.

3.     World Health Organization, Needlestick Safety and Prevention, Independent Study.

4.     MD+DI, A Practical Guide to ISO 10993-5: Cytotoxicity: https://www.mddionline.com/practical-guide-iso-10993-5-cytotoxicity

5.     FDA, Understanding Barriers to Medical Device Quality, 2011.

6.     For instance M Song, “4 Important things to consider before designing a drug delivery device,” Pharmaceutical Online, Aug 6, 2019.


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