{"id":1127,"date":"2017-11-21T02:52:10","date_gmt":"2017-11-21T07:52:10","guid":{"rendered":"http:\/\/www.creative-biolabs.com\/blog\/?p=1127"},"modified":"2017-11-21T03:08:32","modified_gmt":"2017-11-21T08:08:32","slug":"fda-taking-new-steps-to-better-inform-physicians-about-biosimilars-through-education-about-these-potentially-cost-saving-options","status":"publish","type":"post","link":"https:\/\/www.creative-biolabs.com\/blog\/index.php\/fda-taking-new-steps-to-better-inform-physicians-about-biosimilars-through-education-about-these-potentially-cost-saving-options\/","title":{"rendered":"FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options"},"content":{"rendered":"

“The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire.Although many companies are keen on getting a share in the biosimilars market given its promising outlook, bringing these complex molecules from bench to launch can be a challenge, not just during the development stage but also in terms of the manufacturing process involved.Key guidance documents and education from FDA aim to help manufacturers utilize recommended methods for developing and testing biosimilars, including a recent draft guidance that outlines statistical approaches for evaluating analytical similarity. “<\/em><\/p>\n

The cost of prescription drugs is an ongoing concern, however, a growing market for potentially lower-cost biological products called biosimilars can offer more competition and options for patients.<\/p>\n

Biosimilars can potentially reduce costs for consumers by creating price competition for products that previously faced few market competitors. FDA wants to ensure that health care providers have the information they need when considering prescribing biosimilars when these products are available.<\/p>\n

An FDA-approved biosimilar is highly similar to \u2014 and has no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from \u2014 an already FDA-approved biological product, called the \u201creference product.\u201d In general, biological products are highly complex and are often used to treat patients with serious and life-threatening conditions.<\/p>\n

\"FDA<\/a><\/p>\n

FDA is working to help ensure that patients and their health care providers are well informed about biosimilars.<\/p>\n

FDA\u2019s Center for Drug Evaluation and Research (CDER) has approved seven biosimilars to date. \u00a0As more biosimilars are approved by FDA, we want health care providers to understand what these drugs are, and how they can help patients. So we are taking new steps to make sure providers are properly informed about biosimilars by launching an educational campaign today.<\/p>\n

We planned and researched extensively prior to developing the materials for this education and outreach effort. Through this process, we learned the specific areas that health care providers had questions about. These include questions about the data and information FDA reviews when it\u2019s making decisions to approve a biosimilar. Based on that feedback, FDA has developed\u00a0educational materials to help health care providers gain a better understanding of these important products and the approval process they undergo. This includes fact sheets and graphics for health care professionals, as well as materials for organizations to use in disseminating this information to their interested members. These resources:<\/p>\n