AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). (See The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling.) In its supplemental petition, AbbVie raises the same arguments and provides “additional relevant information and addresses events that arose after the Petition was filed.” (AbbVie August 10, 2015 Supplemental Citizen Petition at 1.) In particular, AbbVie raises the following: 1) contrary to the FDA’s statements to the Senate Committee on Health, Education, Labor, and Pensions (“HELP Committee”), inclusion of additional information from the Purple Book (see FDA Release a Purple Book for Biosimilars) cannot cure the material omissions caused by the FDA’s current labeling; 2) the FDA and Department of Justice (“DOJ”) have “acknowledged in litigation that it is materially misleading for a prescription drug’s labelling to fail to specify when studies pertain to other, non-identical products”; and 3) a diverse group has requested that the FDA ensure that biosimilar labeling include the information set forth in AbbVie’s initial citizen petition. Id. at 1.

Senate HELP Committee
As noted in AbbVie’s initial citizen petition, the Chairman of the Senate HELP Committee (“Chairman”) sent a letter on April 30, 2015 to the FDA objecting to the fact that the first approved labelling for a biosimilar contained no statement regarding the product’s interchangeability status nor did it include the word “biosimilar.” Id. at 2. The Chairman also noted that the FDA appeared to have made its policy on labeling more uncertain by stating in its draft guidance that information regarding a product’s interchangeability status is “necessary” for health professionals to make prescribing decisions. Id. The Chairman then asked the FDA to explain the circumstances under which it would be “necessary for a biosimilar product to disclose in its labeling that it has not been found interchangeable with its reference product (or other products found biosimilar to the same reference product).” Id. (internal quotations omitted).

The FDA responded on June 22, 2015, after AbbVie’s submission of its initial citizen petition, and once again stated that “health care professionals should have product labeling that includes the essential scientific information necessary to make informed prescribing decisions for their patients.” Id. (internal quotations omitted). However, the FDA told the HELP Committee that interchangeability information did not need to be included in biosimilar labeling because prescribers could obtain the omitted information in the Purple Book. Id. at 2-3.

AbbVie argued that “[t]he proposition that The Purple Book could cure a material omission in the labeling for a biosimilar is indefensible.” Id. at 3. Further, the FDA regulations state that the prescription drug labeling found on or within a package must contain all information required for prescribers to administer the drug safely and effectively to their patients. Id. AbbVie further contended that “[t]his is a foundational principle of FDA law” that the FDA “fought long and hard to vindicate.” Id. According to AbbVie, the FDA’s reliance on the Purple Book as an ancillary source of information is “curiously irrational” where the labeling does not even tell prescribers that the product is a biosimilar. Id. at 4. AbbVie pointed out that, unlike generic drugs that generally have labeling identical to the branded drugs, Congress has recognized that biosimilars and branded biologics are not the same, should not be labeled the same, and should not be substituted unless they are designated as interchangeable. Id. AbbVie also argued that the Purple Book cannot be relied upon for “essential prescribing information” because it does not provide the information the FDA deems as “critical” to support prescribing decisions. Id. at 5.

Amarin Pharma, Inc. v. FDA
AbbVie next turned to statements made by the FDA and DOJ in Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y.). The Director of the Center for Drug Evaluation and Research filed a letter dated June 5, 2015 with the Court that discussed permissible marketing of the new drug Vascepa®. In the letter, the FDA recommended that communications not imply that studies conducted using products other than Vascepa® were studies of Vascepa® itself. Id. Further, the FDA recommended express disclosure that such studies were not of Vascepa® and that the results may not apply to Vascepa®.  Id.  AbbVie also noted that in a brief filed on June 23, 2015 by the DOJ on the FDA’s behalf, the DOJ asserted that it would be “misleading for Amarin to suggest or imply… that studies using products other thank Vascepa were studies of Vascepa itself.”  Id.(quoting FDA, Mem. Of Law in Opp. To Pls. Mot. For Preliminary Injunction, 23 (June 23, 2015), Dkt. No. 51, in Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y.).

AbbVie, drawing a parallel between a biosimilar and branded biologic and Vascepa® and its related products, noted that the FDA approved labeling for Zarxio “relies entirely on studies involving a different product without acknowledging that the studies were not conducted with Zarxio.” Id. at 6. AbbVie noted that the FDA and DOJ have represented that such labeling would be misleading. Id.

Stakeholder Support for Distinct Labeling
Next, AbbVie noted that stakeholder support for distinctive biosimilar labeling is continuing to grow.  Id. AbbVie discussed six examples of stakeholder concern regarding biosimilar labeling. Id. at 6-7. In all of these examples, concern was expressed regarding the accuracy of biosimilar labeling, its failure to require the product be labeled as a biosimilar, and its failure to provide information regarding interchangeability. Id. at 6-8. AbbVie’s cited examples include the following: an April 23, 2015 letter from leading pharmacists to the Acting Commissioner of Food and Drugs (“Acting Commissioner”); a May 19, 2015 panel discussion  of physicians, advocates, and legislators convened under the auspices of the Alliance for Patient Access regarding biosimilar issues, including labeling; a June 9, 2015 letter from the Patients for Biologics Safety and Access to the Acting Commissioner; a June 12, 2015 letter from the Global Healthy Living Foundation to the Activing Commissioner; a July 1, 2015 issuance of survey results from the Coalition of State Rheumatology Organizations’ indicating that 96 percent of the 3,000 rheumatologists surveyed believed the FDA should require a label that identifies the medication as a biosimilar and conveys information regarding its differences from the branded biologic; and a July 9, 2015 statement from the Biosimilars Forum endorsing AbbVie’s petition.

K&L Gates LLP will continue to follow any further developments.