Reports

To date (19 June 2020), the US Food and Drug Administration (FDA) has approved 27 biosimilars, plus four follow-on biologicals [1]. The pipeline for biosimilars continues to grow, however, of the 27 biosimilars approved, only 17 have so far been launched [2].

The US Food and Drug Administration (FDA) has approved 26 biosimilars [1], yet only two are available on the market. A recent exploration [2] of this issue highlights the major obstacles to biosimilar access in the US.

The Generic and Biosimilar Medicines Association (GBMA), which is the representative body of generic and biosimilar medicine suppliers in Australia, has released its quarterly review of biosimilar literature [1].

Increasing the use of biosimilar could have saved self-insured companies in the US up to US$1.4 billion on just two biologicals – infliximab and filgrastim – during 2018.

The Association of Southeast Asian Nations (ASEAN) and China market for copy biologicals was valued at US687.6 million in 2017 and is expected to reach US$5.5 billion by 2025 with a compound annual growth rate (CAGR) of 29.7%, according to a new report by Allied Market Research.

The high cost of originator biologicals in Canada has created a demand for biosimilars as a way of reining in costs for Canadian public healthcare payers. However, although several biosimilars are now commercially available in the country for a variety of conditions [1]; it has been suggested that the uptake of biosimilars in Canada remains low [2].

Each biosimilar has its own unique challenges on the market. At the 2019 Generic + Biosimilar Medicines Conference, Dr Amy Gutierrez, Chief Pharmacy Officer of not-for-profit healthcare plan Kaiser Permanente outlined these factors for four blockbuster drugs: bevacizumab, filgrastim, rituximab and trastuzumab [1].

During the European Commission’s (EC) fifth workshop on biosimilars, which was held in Brussels, Belgium on 30 October 2019, the subject of what policies might maximize the benefit of biosimilars to societies across Europe was discussed [1].

How to optimize the benefits of biosimilars for society was a topic discussed during the European Commission’s (EC) fifth workshop on biosimilars, which was held in Brussels, Belgium on 30 October 2019 [1].

Japan is proving to be a favourable market for biosimilars, with more than half a billion dollars worth in sales waiting for prospective makers of biosimilars.