Juno Pharmaceuticals and Amgen Australia announce partnership for the marketing and distribution of biologic medicines Neulasta® (Pegfilgrastim) and Ristempa® (Pegfilgrastim) in Australia.

MELBOURNE, AUSTRALIA – Juno Pharmaceuticals is pleased to announce that Amgen Australia have appointed us as their distribution partner for the exclusive marketing and distribution of Amgen’s biologic medicines Neulasta (Pegfilgrastim) and the launch of Ristempa (Pegfilgrastim). This will be effective 1 March 2018.

Under the terms of this agreement, Juno will be responsible for the commercial management of these brands in Australia. Amgen will continue to be the sponsor of these brands on the Australian Register of Therapeutic Goods (ARTG) and there will be no changes to the product, packaging, labelling and wholesale distribution of Neulasta. We will ensure there is no interruption to the service provided, and your local Juno Key Account Manager will work with you to provide a smooth transition.

Juno Pharmaceuticals is a rapidly growing, local Australian and New Zealand business with expertise in both biosimilars and off patent medicines. Members of the Juno team have had previous experience in the launch and management of a number of biosimilars both in Australia and abroad, including the first and leading biosimilar filgrastim in Australia. Juno’s current portfolio includes medicines across a diverse range of therapeutic areas, with hospital products the core focus of the business and a strong pipeline of complex molecules.

This partnership is a major milestone in Juno’s continued growth and strategy of diversification and expansion into the biologic and biosimilar markets. The partnership is also in line with Juno’s mission to improve the health of society, through delivering high quality products to patients, and value to hospitals, the government and tax payers.

Canadian Biosimilar Approval Process Update

The Canadian Agency for Drugs and Technology in Health (CADTH) are revising the regulatory process for biosimilars. Following a period of consultation, CADTH has streamlined the assessment process for biosimilars, with shorter approval timelines, fewer submission requirements and abbreviated biosimilar dossier templates. The overall review timeline for biosimilars will be cut in half to three months, with fees also reduced.

Reference: Canada cuts assessment times.Generics Bulletin,2018;344:9

Introduction of Biosimilar Uptake Drivers in Australia

New biosimilar uptake drivers negotiated late last year, including ‘streamlined authority’ prescribing appear to be making a positive impact on uptake.¹ Further information on the uptake drivers can be found at http://www.pbs.gov.au/general/biosimilars/biosimilar-uptake-drivers-q-and-a.pdf

Med188. Prepared April 2018.

Reference: 1. Pharma Dispatch. Positive early signs for new uptake drivers. Mar 23rd, 2018. Available at: https://pharmadispatch.com/news/positive-early-signs-for-new-uptake-drivers. Accessed: April 2018

Biosimilar Nomenclature in Australia

In 2017, the TGA opened a public consultation regarding the naming of biosimilars. The objective of this consultation was to determine whether biological medicines in Australia required additional naming requirements, in order to strengthen traceability and pharmacovigilance¹.

The options proposed were¹:
1. Maintain the status quo. Use the agreed Approved Biological Name to identify the active ingredient in both the reference product and all subsequent biosimilars. Unique identification of individual products would rely on its allocated Australian registration number (AUST R) and proprietary trade name.
2. Maintain the status quo with activities that increase public reporting of adverse events with the inclusion of the product’s trade name, AUST R and batch number. Currently the trade name is a non-mandated field on TGA’s forms for reporting adverse events as a prescriber who wishes to report an adverse event in relation to a patient may not know what product was supplied to the patient by the pharmacist. This option would focus on increasing education to healthcare professionals and the public to report all medicines, particularly biosimilars, associated with adverse events by their trade name, AUST R and with the associated batch number.
3. Move towards adopting a barcode system similar to the EU. The EU has mandated that most medicines supplied in the EU must have a unique identifier (a 2-dimensional barcode) placed on the packaging no later than February 2019. This bar code contains information including the product code, national identification number, batch number and expiry date. The barcode system allows traceability of batches of medicines from the manufacturer to individual patients as well as aiming to prevent falsified medicines entering the legal supply chain and improved pharmacovigilance
4. Introduce the use of suffixes to the naming of biological medicines. Use of suffixes to uniquely identify all biological medicines would be consistent with the approach taken by the US FDA. The FDA Approved Biological Name is to be used as the core name, but each product would have a unique suffix associated with the FDA Approved Biological Name. This option would make the biosimilar and reference biological brands appear as different drugs for prescribing purposes because they would be presented as distinct entries in prescribing lists and would therefore be displayed separately for the prescriber to choose from. This may undermine the scientific findings concerning their level of similarity.

Following the consultation, the TGA has decided it is not necessary to add a brand specific suffix and will maintain the current naming convention for biosimilars, keeping Australia’s nomenclature in line with that of the European Medicines Agency (EMA). Adverse event reporting will be strengthened, via making the product’s trade name and non-proprietary name a mandatory field when reporting an adverse event to TGA².

References:
1. TGA. Consultation: Nomenclature of Biological Medicines, 2017. Available at https://www.tga.gov.au/sites/default/files/consultation-nomenclature-biological-medicines.pdf. Accessed April 2018.
2. TGA. Submissions received and TGA response: Nomenclature of biological medicines. Available at: https://www.tga.gov.au/submissions-received-and-tga-response-nomenclature-biological-medicines. Accessed April 2018.
Med184. Prepared April 2018.