Mario DiPaola: “The past few years have seen the biosimilar field expand dramatically. A number of companies have entered this biosimilar space, developing a number of biosimilars of several blockbuster biopharmaceuticals. While the biosimilar field is relatively young, six biosimilars have already been approved by the FDA. The combination of these early successes along with a second wave of biopharmaceuticals, undergoing patent expiration in the next few years, will trigger even more interest in biosimilars. Thus, I anticipate that this sector will continue to grow faster than other sectors of the pharmaceutical and biopharmaceutical industry. Furthermore, the introduction of new guidelines by the FDA, providing a regulatory pathway for product interchangeability, should provide additional impetus for biosimilar development.”
Christina Satterwhite: “I would anticipate that over the next 5–10 years an increasing number of industry driven white papers and additional guidelines will be published regarding biosimilar drug development. The knowledge and experience gained over the last several years in many areas such as CMC, nonclinical and clinical assay development and validation, clinical trial design, PK/PD considerations and requirements for interchangeability should be shared through publications, workshops and presentations. The main obstacle for biosimilars to get to market will be litigation hurdles that will inevitably need to be considered.”
Fernando de Mora:“Biosimilars development and launch is now increasing fast and, in my view, it will rocket in the next 5–10 years as experience is gained and patents expire. Patients need biosimilars and companies can address that need. The initial resistance to enter the market was linked partly to a poor regulatory know how and market uncertainty because of barriers to entry of such products. However, the landscape is changing. Biosimilars have proven to be effective and very beneficial with opportunities now being seized and both generic and innovator companies acknowledging it.”
Arno Kromminga: “With the increasing number of biosimilars the overall knowledge about these will increase.”
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