Guarantee of supply

The guarantee of supply requirements apply to newly listed brands that are bioequivalent or biosimilar to an existing listed brand and have the same drug and manner of administration.

The new brand could be listed under the same pharmaceutical item as the existing bioequivalent/biosimilar brand or as a different item. It is known as the guaranteed brand. Where two or more bioequivalent or biosimilar brands are listed on the Schedule of Pharmaceutical Benefits on the same date, they will each be subject to the guarantee of supply requirements (regardless of whether there is an existing bioequivalent item on the Schedule of Pharmaceutical Benefits). 

The Responsible Person for a guaranteed brand must be able to supply the guaranteed brand within a reasonable period after receiving a request to supply from a wholesaler or approved pharmacist.

Listing a new item does not trigger a guarantee of supply requirement, unless that item is bioequivalent or biosimilar to an existing item.

The guarantee of supply requirements also apply to existing brands on the Formulary F2 (including F2A and F2T) that offer a voluntary price reduction which is accepted by the Minister and published on the Schedule of Pharmaceutical Benefits.  If two brands offer the same reduced price (and these are accepted by the Minister) the brand that was first to offer that amount will become the guaranteed brand.

Where the guaranteed brand is supplied for a number of indications the supply requirement extends to prescriptions under all indications.

The guarantee of supply period begins:

• On the day of the new brand listing or the effective date of a lower price offer and ends after 24 months OR;
• When a new bioequivalent or biosimilar brand of that drug lists or an existing bioequivalent or biosimilar brand of a drug lists at a lower price.

For more information, contact the Listing Unit as detailed on the PBS Contacts  page