By Peyton HowellThe pharma industry has begun a new chapter of the biosimilars story. We now have much-anticipated guidance from the FDA on what the approval pathway will look like, what evidence can be used from a branded innovator, and a sense of how cumbersome the approval process might be for manufacturers of biosimilars. Based on the guidance, the process of bringing a biosimilar to market will likely require many of the strategies used to bring a branded product to market, which will impact the commercialization of the products and likely reduce potential cost savings. The explosive growth in the costs associated with pharmaceuticals, particularly highly complex specialty products, continues to be a significant barrier to curbing overall healthcare spending in the United States. As such, biosimilars are expected to decrease or at least control rising pharmaceutical expenditures by offering considerable savings for high-cost biologic products. According to the Congressional Budget Office, biosimilars are expected to save $13 billion over the next 10 years. Initially, from the payer perspective, biosimilars were expected to generate 30% to 40% savings; however, as the complexity of bringing biosimilars to market continues to be discussed, more recent data suggest that most payers anticipate a biosimilar will come in between 10% to 20% less than the cost of the branded manufacturer. In Europe, we know that biosimilars have often been just a 10% discount from the brand. Figure 1 illustrates trending payer opinions based on Xcenda's proprietary research with advisers who participate in a managed care network. There has been a significant shift from payer perception on savings between 2010 and 2011.The premise of biosimilar cost savings is that the FDA approval pathway is significantly less arduous than that of a branded biologic. In November 2010, the FDA held a public meeting on biosimilars, which included representatives from both branded and generic manufacturers. Not surprisingly, branded manufacturers cited the need for independent evidence and strong data to support approval by the FDA. On the contrary, generic and potential biosimilar manufacturers identified that the purpose of such a pathway is to ensure products can be approved based on innovator data and in a reduced time frame to improve access to lower-cost products.On Feb. 9, the FDA released the first substantive information since the passage of the ACA in the form of three guidance documents that provide some insight into the approval pathway for biosimilars. These regulatory guidances suggested some wins for biosimilar manufacturers, as the FDA clarified that some ex-U.S. and branded innovator data can be used to support a biosimilar application for approval. Additionally, the FDA suggested that biosimilar manufacturers will be allowed to extrapolate innovator data to support the approval of all indications the branded product is approved for. While these may reduce the overall resources required to bring a biosimilar to market, there were other aspects of the guidance that were not as favorable to these stakeholders. For example, the FDA discussed some methodological approaches to examine interchangeability; however, the guidance suggests that the FDA does not believe the current technology is evolved enough to truly establish interchangeability. While these documents provide some clarity from the FDA regarding evidence aspects of the approval pathway, the lingering issue with interchangeability may prove to be a barrier for biosimilar manufacturers from the utilization and payer management perspectives. Based on Xcenda research, in order to require an existing patient to switch to a biosimilar:-- Payers will want to see greater than a 40% cost savings (see Figure 2) for an existing patient to require a switch-- Interchangeability will be a key factor in requiring a switch-- The savings is lower for a new start patient (21% to 30%), indicating that read more..
Monday, 9 July 2012
Interchangeability-Biologic Products-Fda Guidance-Cost Savings-Biosimilars
Wednesday, 21 March 2012
Food And Drug Administration-Television Advertisement-Prescription Drugs-Warning Letter
On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").
Before I get to the "loophole," here's a summary of the guidance.
Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.
Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:
- Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug
- Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act)
- Category 3: All TV ads for Schedule II controlled substances
- Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling
- Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter
- Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision
Regarding the 45-Day Review Period, FDA says:
"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."
That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.
What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.
"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review packag read more..