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BioBlast w/e 25 Nov 22: AbbVie’s risankizumab, FDA investigating Prolia® (denosumab) risk, Amneal’s filgrastim launch, Junshi Biosciences’ adalimumab, US biosimilars bill, Teva and Sandoz biosimilars ramp-up

by , | Nov 29, 2022

Significant biosimilar activities this week include:

23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s disease

AbbVie announced that Skyrizi® (risankizumab) has been approved for the additional indication of Crohn’s disease by EMA.  This is the first specific interleukin-23 inhibitor to be approved for Crohn’s disease.

22 Nov 22 | US | FDA investigating risk of Prolia® (denosumab) in advanced kidney disease

The FDA announced that it is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with Amgen’s Prolia® (denosumab).  According to the announcement, FDA’s review of interim results of ongoing safety studies suggested an increased risk of hypocalcemia in patients with advanced kidney disease, and a substantial risk with serious outcomes including hospitalization and death.

22 Nov 22 | US | Amneal launches Releuko® (biosimilar filgrastim) in the US

Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019.  This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (biosimilar bevacizumab) in October 2022.

22 Nov 22 | CN | Junshi Biosciences obtains additional indications for 君邁康® (biosimilar adalimumab) in China

Junshi Biosciences announced today that China’s NMPA has approved its supplemental application for additional indications for 君邁康® (biosimilar adalimumab) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children.

22 Nov 22 | Biosimilars boom is upon us, as Teva and Sandoz plan biosimilars ramp-up

Reuters reported that Teva and Sandoz are planning a significant ramp-up in production of biosimilars.

According to Reuters:

  • More than 55 blockbuster biologics will come off patent protection over the next decade, and account for more than $270 billion in expected peak annual sales;.
  • The value of the global biosimilar market could more than triple to an estimated $74 billion by 2030.
  • Sandoz is currently the second biggest player after Pfizer in the biosimilar market by gross sales globally. Amgen is in third place).
  • Sandoz has launched eight biosimilar drugs, has 15 products in development, and in the next five years would like to double the value of its marketed portfolio
  • Teva has 3 approved biosimilars and 13 in development.
  • EMA has approved more than 50 biosimilars, and biosimilars have taken the majority of market share from brand-name biologics in Europe and resulted in savings between 75% to 90% off the reference product prices.
  • FDA has approved 39 biosimilars and 22 products have been launched as of October 2022.

22 Nov 22 | US | Merck Announces positive results from Phase 3 trial of KEYTRUDA® (pembrolizumab) combined with chemotherapy in gastric cancer

Merck announced positive results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Merck reported that the treatment showed significant and clinically meaningful improvement in the trial’s primary endpoint of overall survival (OS), and that significant and clinically meaningful improvement in progression-free survival (PFS) and overall response rate (ORR) were also observed.  Keytruda is already approved by the FDA and elsewhere for other gastric and GEJ tumours.

17 Nov 22 | US | New biosimilars bill aims to remove interchangeable requirement for pharmacy substiution

Senator Mike Lee (R-UT) introduced the Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation.

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