Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
Oncology Biosimilars Approved by the Food and Drug Administration
The first biosimilar for Rituxan (rituximab) received FDA approval in December. Truxima (rituximab-abbs) has 3 of the oncology related indications of the reference product but there are other indications which are not included in the label.1 These indications include additional oncology uses as well as rheumatoid arthritis among others. Generally speaking, the FDA has previously approved the biosimilars with the same indications as the reference drug. How will this impact the uptake of this biosimilar? Will limited labels compared to the reference product become more common? Many things are ‘to be determined.’ Additionally in December, the FDA approved two biosimilars for Herceptin (trastuzumab) for the treatment of certain types of breast cancers.2,3 Ogivri (trastuzumab-dkst) by Mylan and Herzuma (trastuzumab-pkrb) by Celltrion Inc. have the same indications and warning as Herceptin.
FDA provides Draft Guidance on Development of Medications for Liver Disease
In December, the FDA provided guidance to the pharmaceutical manufacturer industry for the development of products to treat the condition referred to as NASH.4 NASH is nonalcoholic steatohepatitis and is sometimes referred to as fatty liver. The guidance provides information and details which may assist the drug developers in obtaining expedited reviews as well as potentially improve chances of FDA approval based on certain measurements. This particular therapeutic category is of significant interest as there is currently an unmet need as well as a large potential patient population. Currently there are no approved drugs for the treatment of NASH.5 There are multiple pharma and biotech companies racing to get their NASH treatment to market including Allergan, Genfit, Gilead and Intercept Pharmaceuticals. The pharmaceutical management of NASH has been projected to be billions of dollars considering risk factors include obesity and diabetes.
Several Pharmaceutical Companies Plan to Raise Prices in January
For the past several years just like clockwork, one could count on pharma companies taking price increases at the beginning of the calendar year. There was significant scrutiny on the pricing tactics and strategies in 2018. So much attention that many pharma companies decided to not hike prices in 2018. With 2019 here, that strategy has expired. It is being reported that many pharmaceutical companies will be increasing the prices throughout their drug portfolio in January.6 It is suggested by the pharma companies that the end cost increase is lessened by improved rebates and discounts.6 Pricing of medications is going to remain a hot political topic for 2019 and beyond.