Sandoz’s Biosimilar Zarxio Marketplace Entry Delayed

Sandoz’s  Biosimilar Zarxio Marketplace Entry Delayed

Patients will need to wait for Zarxio,the biosimilar of Amgen’s cancer treatment Neupogen. Zarxio is the first biosimilar that was approved (March 6, 2015) in the United States under the abbreviated approval pathway of the Biologics Price Competition and Innovation Act (BPCIA).  The direct link to the federal court of appeals opinion is below.

Synopsis—In an Appeal from the United States District Court for the Northern District of California in No. 3:14-cv-04741-RS, the Federal Circuit Court of Appeals on July 21, 2015 interpreted the advance notice provision in a manner that effectively delays marketplace entry. This means that Sandoz’s release of Zarxio, its biosimilar of Amgen’s cancer treatment Neupogen, will not occur until Sept. 2. How the Court of Appeals interpreted the advance-notice provision is a significant victory for brand-name biologics.

District Court Interpretation—The district court had determined that the statute only required it to provide notice 180 days before it commercially marketed the biosimilar and that Sandoz had given Amgen such notice on July 14, 2014, when it filed its biosimilar application with the FDA.

Federal Court of Appeals Interpretation—Yet, the federal court of appeals, determined that notice of a biosimilar must be given to the biologic brand reference product sponsor (RPS) not later than 180 days after the Food and Drug Administration approves/licenses the biosimilar. The court of appeals stated: “We agree with Amgen that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product. That is,the Appeals Court determined that based on the language in the BPCIA, notice be provided after the biosimilar product is licensed by the FDA.

The direct link to the official Federal Circuit opinion is: Amgen, Inc. v. Sandoz, Inc.

Calorie Disclosure FDA Final Rule Effective Date Extended to 2016

Quick Summary-Final Rules for Vending Machines and Restaurant Menu Labelling 

New Effective Date December 1, 2016 for both Rules

Key Links

Background: In December 2014, FDA released two final rules regarding caloric disclosure for final publication in the Federal Register. The rules were proposed in April 2011 under section 4205 of the Affordable Care Act and are both now effective December 1, 2016.

Reason for Vending Machine Rule-Food Labeling; Calorie Labeling of Articles of Food in Vending MachinesThe purpose  of the final rule is to assist consumers by requiring the availability of point of purchase nutrition caloric information prior to purchasing the food item. 

Vending Machines-Who Must Comply? Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.

Reason for Food Labeling Rule: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. The purpose of the final rule also published December 1, 2014 is to implement the menu labeling provisions of the Affordable Care Act to assist consumers by requiring the availability of point of purchase nutrition caloric information for informed decision making prior to purchasing the food item.  See FDA Summary Below.

Menu Labelling-Who Must Comply? Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.

FDA Summary: A restaurant or similar retail food establishment is generally defined as a retail establishment that offers for sale restaurant-type food, which is generally defined as food that is usually eaten on the premises of the establishment, while walking away, or soon after arriving at another location. Examples of restaurants and similar retail food establishments include sit-down and fast-food restaurants, bakeries, coffee shops and grocery and convenience stores. The menu labeling final rule also requires calorie labeling for certain alcoholic beverages and certain foods sold at entertainment venues such as movie theaters and amusement parks. The FDA also clarifies in the menu labeling final rule that certain foods purchased in grocery stores or other retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats and cheeses and large-size deli salads, are not covered.To help consumers understand the significance of the calorie information in the context of a total daily diet, the FDA is requiring a succinct statement that says, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” to be included on menus and menu boards. The menu labeling final rule also requires covered establishments to provide, upon consumer request, written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein.

The vending machine final rule requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exceptions. Vending machine operators that are covered, including those that voluntarily register with FDA to comply with the vending machine labeling requirements, will have two years from the date of publication of the vending machine labeling final rule to comply with the requirements.

Conclusion and Recommendation The caloric disclosure is a step in the correct direction since the obesity rate and diet related diseases has again risen in the United States. Is caloric disclosure sufficient in terms of right to know? What other disclosures should FDA institute?