Recently, I went to the pharmacy and paid twenty-two dollars for a generic statin prescription. A related statin as a new brand might cost six hundred dollars. While I earn my daily keep in the biopharma services sector and appreciate why drugs cost so much, this made me happy as a consumer.
The Role of Biologic Drugs
Enter, biologics. Without a doubt, since innovators have brought to market therapeutic antibodies and other biologic drugs these biopharmaceutical products have improved and saved countless lives. To patients the cost of these magic bullets is unquestionably worth it. To patients and payers the economics of such treatments is the subject of a different kind of suffering. On a different order of magnitude but equally gratifying, a spate of biosimilar approvals is beginning to mitigate the economic suffering of countless patients.
FDA’s Commitment to Biosimilar Availability & Affordability
On November 15, an FDA press release noted CDER has to date approved twenty-five biosimilars, the most recent Pfizer’s Abrilada, a biosimilar to Humira, on that day, and expressed their commitment to foster competition and continue facilitating the availability of more affordable biologic drugs. Good news for payers and patients!
Analytical Considerations for Biologic Products
It is difficult enough to develop any biologic product, be it an innovator or a biosimilar. In the CMC realm product characterization must include not only the ubiquitous identity, purity, and stability characterizations, which take on another dimension in the biologics space, but also potency, which may involve development and validation of complex cell-based assays. Moreover, in the case of biosimilars, analytical characterization may need to be more expansive to show sameness of critical quality attributes. For proteins this means secondary characteristics such as charge heterogeneity and glycosylation patterns be determined and referenced against innovator product. To quote Amgen, while a biosimilar may require fewer clinical trials than its reference product in order to attain approval, it may also require a greater preponderance of analytical characterization [USA-BIO-122466(1)].
As with small molecule generic drugs time to market is a driving force for companies developing biosimilars. Thus, one needs not only the right expertise and tools but also analytical service partners that are agile and responsive to real-time needs and budgets of the stakeholders.
If your company is planning to make the leap into biologics, you should familiarize yourself with the essential analytical approaches you will need to ensure your products will be safe and effective in a clinical setting. For more information, check out our whitepaper, Appropriate Methods When Developing Novel Biologics.
Our featured blogger is Bob Plourde, Avomeen’s Senior Director of Business Development for the Western USA. Bob has been involved in many aspects of the biopharmaceutical industry for more than 20 years, including carrying out drug discovery and development, roles in project management, and most recently serving in business development roles for organizations that provide solutions for biopharmaceutical research and development.