A biosimilar may only be authorised for the indications and conditions of use previously authorised for the reference product, but a biosimilar may be authorised for unless all the indications and conditions of use authorised for the reference product. Therefore, it is important for healthcare professionals to review the product labelling (prescribing information) to determine the conditions of use and routes of administration for which the biosimilar has been authorized. AHIP: “Remove state-level barriers that restrict the use of biosimilars. Although the Affordable Care Act has authorized the FDA to develop a shortened approval pathway for biosimilars, final standards have yet to be published to determine when a biosimilar is truly interchangeable with an already approved biologic. Prior to these standards, some states have already passed laws that can limit the availability of biosimilars before they even reach the market. These proposals will limit patients` access to drugs that are not clinically different, but cost much less than their branded counterparts. (America`s Health Insurance Plans in “Specialty Drugs – Problems and Challenges,” June 2014) New Jersey is the only other state with a biosimilar substitution bill pending in its legislature, according to the National Conference of State Legislatures. A pharmacy or pharmacist filling a prescription for a biologic cannot replace the biologic with a biosimilar unless certain conditions are met, including notifying the patient to whom the product is prescribed and the physician or physician`s staff; requires the pharmacy and pharmacist to keep a surrogate record; requires the Board of Pharmacy to publish a list of interchangeable biosimilars on its website. Readers who wish to learn more about U.S. state legislation and biosimilarity and interchangeability in the U.S. are invited to visit www.gabi-journal.net to see the following manuscripts published in the GaBI Journal: Currently, there is concern that traditional laws governing “generics” may be misapplied to new products that are not identical. This recently led to a decision to amend old state laws to address the medicinal and chemical properties of these “biologics,” as well as future generic or “biosimilar” “follow-up biologics.” On Friday, March 6, 2015, the U.S. Food and Drug Administration (FDA) approved the first biosimilar in the U.S.
using the authority under the Affordable Care Act. Since the introduction of biosimilars to the market could lead to measurable cost savings and better access to therapeutic treatment for chronic diseases, the following information may be relevant to the patients and populations you serve. Allows a pharmacist to replace a prescription biosimilar with a replaceable biosimilar when notified by the prescribing physician and the patient; and the prescribing physician signed “May Replacement” on the prescription. Requires the pharmacist to keep related records. Requires the Pharmacy Board to maintain a list of all approved products that are interchangeable on its website. Prescribed written or electronic prescriptions must comply with existing requirements for the prescription form. The right to substitute a valid reason has no limit on how often it can be invoked, so the parties can exercise the right until they have found a neutral judge. Substitution by a cause can be postponed at any time after a party realizes that there is bias. However, many jurisdictions require that the right be exercised within a certain period of time after the bias has been discovered by a party, otherwise the right is waived, often 30 to 60 days. Here are some important definitions that policymakers should understand when reviewing regulations, with examples taken directly from state laws: Senator Hill reintroduced a biosimilars law, SB 671, which addresses many of the same provisions, including notifying the supplier to replace only interchangeable biosimilars, and a physician`s ability to prevent substitution.
The outlook for this bill looks good, and this year many other parties have added their support. Only one biosimilar in the U.S. – the sandoz version of Novartis subsidiary Amgens Neupogen (Filgrastim) – managed to pass an advisory board meeting with the U.S. FDA. The Biotechnology Industry Organization (BIO) congratulated the Governor of California for “signing essential legislation to create a pathway for substitution of interchangeable biologic drugs.” Jim Greenwood, president and CEO of BIO, added that the bill “includes communication on all biologic drugs that are dispensed to maintain a consistent and complete medical record.” Provides that a pharmacist may replace a commercial or branded biologic with an interchangeable biologic unless “the prescribing physician instructs otherwise in writing.” If a replacement is made, the prescribing physician must be notified in writing within a “reasonable time”, including through an electronic health record (EHR). In addition, the patient or his/her authorized representative must be informed of the substitution. Pharmacists, prescribers and medical practitioners must keep a register of substitutions for at least one year. Empowers the Ministry of Health to make regulations and determine their application. The Act also includes an important provision requiring a pharmacist to inform a patient within 5 days of dispensing the drug of the substitution of a biosimilar for a biologic and the prescribing physician. (See Rx Database, keyword “Organic Products” for more details). Amending Act 247 of 2004, known as the Pharmacy Act, to create the definition of biosimilars, it sets requirements for the distribution of biosimilars in Puerto Rico.
The California bill, which was introduced in the state Senate last Friday, has the same requirements as the Illinois bill, but does not impose timelines when prescribers must be notified, nor does it require pharmacists to keep records of biosimilar prescriptions. (See Rx Database, keyword “Organic Products” for more details). Provides that a pharmacist may replace a prescribed biologic with an interchangeable biologic only if all of the following conditions are met: (1) the U.S. FDA establishes lists interchangeable with the prescribed biologic, (2) the prescribing physician does not determine orally, in writing, or electronically that substitution is prohibited, and (3) the pharmacy informs the patient of the substitution. Within 5 working days of dispensing a biologic, the community pharmacist or pharmacist designated by the pharmacist shall register the specific product made available to the patient, including the name of the product and the manufacturer. Communication is made by means of an electronic record, a pharmacy benefit management system or a pharmaceutical record. GPhA applauded states that use compromise wording such as “passing laws that create a competitive market for biosimilars and provide patients with access to affordable versions of these critical drugs.” Concerns the supply of interchangeable biological biosimilars. Allows pharmacists to dispense a biosimilar that has been approved by the FDA as interchangeable with a prescribed biologic, unless the prescribing physician indicates that such substitution is not authorized or the patient insists on dispensing the prescribed biologic. The pharmacist or his representative must inform the patient before dispensing the interchangeable biosimilar and disclose the retail costs. The provisions on notification expire on 1 July 2015. California`s Innovative New Biological and Biosimilar Drugs Act is back for the 2015-2016 session. Amendment to the Pharmacy Practice Act to allow for the substitution of an interchangeable biologic.
Biosimilar: a biologic that is very similar to a particular reference biologic despite slight differences in clinically inactive compounds, so there are no clinically significant differences between the reference biologic and the biologic approved as a biosimilar pursuant to 42 U.S.C. Section 262(k) with respect to safety, the purity and efficacy of the product. [from VA H1422 from 2013] California Governor Jerry Brown signed Senate Bill 671 on October 6, 2015, after it was passed by the California Senate and Assembly. An earlier attempt to pass a law in California, SB 598, which some say hindered access to biosimilars, was rejected by California Governor Jerry Brown in October 2013 [3]. A pharmacist filling a prescription for a prescribed biologic can only select a biosimilar if both of the following conditions are met: For more information on state-to-state biosimilar laws, see our updated table of state biosimilar substitution laws.