Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

The California State Assembly became the latest state legislature to move forward with bills that specifies requirements under which pharmacists can substitute biosimilars for brand-name products. The bill 

 passed the California State Assembly on Aug. 26, 2013, and now moves to the California Senate for a final vote. 

The bill, which amends California’s state pharmacy law, specifies that a pharmacist filling a prescription order for a prescribed biological product may select a biosimilar only if the product is approved by FDA and the prescriber (i.e., the doctor) does not personally indicate “do not substitute” for the product. For prescriptions filled prior to Jan. 1, 2017 for a biological product or interchangeable biosimilar, the pharmacist must notifiy the prescriber (i.e., doctor) whether the prescription dispensed was a biological product or interchangeable biosimilar or enter the information in a patient record system shared by the prescriber. The bill would prohibit a pharmacist from selecting a biosimilar unless the cost is the same or less than the cost of the prescribed biological product. The bill also requires that the substitution of a biosimilar be communicated to the patient. 

State legislatures have become a key focal point for biosimilar as the industry waits for a final US regulatory pathway for biosimilars. The Patient Protection and Affordable Care of 2010, the landmark healthcare reform package signed into law (Public Law 111-148) by President Barack Obama on March 23, 2010, authorized a regulatory pathway for biosimilars (1). In February 2012, FDA issued three draft guidances relating to biosimilars (2-4), but these guidances have not been finalized. The approval pathway, as established by the federal law, distinguishes between biologic products that are “biosimilar” to an innovator biologic, meaning they are “highly similar” to an innovator product, and biologic products that meet a heightened standard to be deemed “interchangeable” (5). Although FDA’s role in the approval of biologic and biosimilar medicines includes the designation of an interchangeable status, the policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed is governed by state law (5), and it is that issue that has been the recent focus of many state legislatures. 

As of August 2013, four states–Oregon, Utah, Virginia, and North Dakota, have passed legislation specifying requirements for biosimilars although the measures in Oregon, Utah, and Virginia contain sunset provisions, 

according to information from the Generic Pharmaceutical Association (GPhA)

. Twelve states—Arizona, Arkansas, Colorado, Delaware, Indiana, Illinois, Maryland, Mississippi, Nevada, Texas, and Washington State—have introduced but not passed such biosimilar legislation. In addition to California, such legislation is pending in Massachusetts and Pennsylvania. Legilsation bill is currently pending in Massachusetts and Pennsylvania, according to information from GPhA.  

www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/

Draft Guidance for the Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 

 Draft Guidance for the Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Draft Guidance for the Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

BIO Principles on Patient Safety in the Substitution of Biologic Products

Articles

The California State Assembly becomes the latest state to specify requirements allowing substitution of biosimilars.

California State Assembly Passes Biosimilar Legislation

Johnson & Johnson completed its acquisition of Aragon Pharmaceuticals

, a pharmaceutical discovery and development company focused on drugs to treat hormonally-driven cancers.  Development of compounds from Aragon’s androgen receptor antagonist program, including its androgen receptor signaling inhibitor, ARN-509, will be managed by Janssen Research & Development.

Source: 

Johnson & Johnson completes acquisition deal with Aragon Pharmaceuticals.

Johnson & Johnson Completes Acquisition Of Aragon Pharmaceuticals

, a biological materials resource and standards organization, announces material deposit agreements with more than 30 public and private institutions.  These institutions will have the option to participate in the biomaterial contributor network (BCN), and make research materials available to the research community. ATCC will coordinate with technology transfer offices at each institution to create a process for adding microbial strains and cell lines to the ATCC collection. Participants will have an opportunity to receive a share of the revenue from the sale and licensing of materials developed at their institutions.  Over 225 biological materials are deposited under these agreements to date, with most available to both contributors and others as determined jointly by ATCC and the institution.

Source: 

ATCC creates Biomaterial Contributor Network to assist the research community.

ATCC Announces Creation of Biomaterial Contributor Network

announced that James Stewart will become CIO of the Merck Group in October 2013. As CIO, Stewart will report to Kai Beckmann, member of Merck KGaA’s Executive Board. Stewart succeeds Frédéric Wohlwend, who has decided to pursue opportunities outside Merck.
  
  James Stewart joined the biopharmaceutical division of Merck KGaA in 2011. Prior to joining Merck KGaA, he had a career with MSD (in the U.S.: Merck & Co.), where he started in Human Resources and progressed through several global business and functional leadership roles.
  
Source: 

Merck KGaA Names James Stewart CIO

Pharmstandard OJSC has completed a transaction to acquire a 100% share capital in Bever Pharmaceutical in Singapore. Earlier this month, 

The amount of the transaction is $590 million. The transaction will be funded by the combination of Pharmstandard’s shares and global depository receipts (GDRs) owned by Pharmstandard-Leksredstva OJSC in the amount of $542 million and cash of $48 million, which may be financed from external sources. Pharmstandard-Leksredstva OJSC currently holds Pharmstandard's shares and GDRs on its balance sheet at approximately $475 million. The company expects that all settlements will be finalized by the end of December 2013.  

Pharmstandard acquired Bever to bolster its over-the-counter (OTC) business, which includes securing a long-term fixed cost supply of two OTC APIs. It is expected that Bever will be included in a proposed spin-off of Pharmstandards OTC business. 

The Russian pharmaceutical company PharmaStand finalizes deal for acquiring Bever, a Singapore pharma company.

Pharmstandard OJSC Completes Transaction to Acquire Bever Pharmaceutical

has filed a petition with the US Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Agency (DEA) to schedule the company's anti-epilepsy drug.
  

Fycompa (perampanel), a new chemical entity, approved by FDA in October 2012 as an adjunctive therapy for the treatment of partial onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. FDA sent its scheduling recommendation for Fycompa to the DEA in January 2013, but the DEA has not yet begun the scheduling process, according to Eisai. 
  

In its petition for a writ of mandamus, Eisai asserted that the DEA has "unreasonably" and "egregiously" delayed the scheduling of Fycompa. The petition also challenges the justification for the delay and highlights the lack of a timetable, predictability, or transparency related to the DEA's scheduling process. In addition, Eisai asserts that the DEA's delay also continues to harm Eisai by preventing it from launching Fycompa in the United States even though Eisai demonstrated to the satisfaction of FDA that the drug is safe and effective when prescribed in accordance with its labeling.
  

FDA requires that sponsors of drugs that FDA recommends for scheduling wait until the scheduling process is finished before commercially distributing the product. 
  

Eisai files a petition with federal appeals court to require the Drug Enforcement Agency to put anti-epilepsy drug Fycompa on the controlled list of substances.