BioBlast®

Coherus released its Q420 and Full Year 2020 financial results. Coherus reported it has captured 21% of the pegfilgrastim market and nearly 50% of the pre-filled syringe segment in the US. Additionally, Coherus announced it plans to file its BLA for its ranibizumab biosimilar mid-year 2021. Coherus also confirmed that it plans to launch its adalimumab biosimilar in the US on or after July 1, 2023.

In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021. Additionally, Fresenius Kabi announced it will launch its biosimilar pegfilgrastim in the US and the EU in Q3/4 2021. Fresenius Kabi’s biosimilar tocilizumab candidate is planned for launch in the US and the EU in 2023. An undisclosed autoimmune biosimilar is planned for a 2024 launch, and an oncology biosimilar in 2025.

The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. 

Pfizer releases its Q2 FY20 financial results. Pfizer reveals that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.

A new study published by the Journal of Clinical Pathways demonstrates significant cost-savings generated by Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

In an interview with Generics update, Sandoz Canada announces it is aiming for 10 biosimilar launches in the next decade, with pegfilgrastim and rituximab to be launched shortly.

Pfizer announces the FDA has approved Nyvepria® (pegfilgrastim). Nyvepria® is indicated to decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Canada. Fulphila® is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Australia. Fulphila® is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections.

Amgen sues Hospira in the District Court of Delaware, alleging Hospira’s aBLA for a proposed pegfilgrastim biosimilar infringes Amgen’s Neulasta patent for protein purification (no. 8,273,707).​

Biocon announces its supplemental BLA (sBLA) for biosimilar pegfilgrastim has been approved by the FDA. This additional approval relates to FDA approval of Biocon’s new manufacturing facility in Bengalaru.

Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.

FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

The CHMP adopts a positive opinion for Mundipharma’s pegfilgrastim candidate, recommending marketing authorisation be granted.

Australia’s TGA approves Ziextenzo® in 6mg/0.6mL solution for injection prefilled syringe for the treatment of cancer patients following chemotherapy.

Amgen and Mylan enter joint status report in US District Court agreeing Mylan did not infringe Amgen’s ‘707 patent. This comes after the Federal Court affirmed Sandoz did not infringe Amgen’s ‘837 patent either.

Coherus reports “victory” in patent dispute with Amgen, announcing that the US Federal Circuit affirmed the District Court’s (Delaware) finding that Coherus’ biosimilar Udencya® does not infringe Amgen’s 8,273,707 patent.  Amgen commenced this BPCIA suit on 10 May 2017, the District Court granted Coherus’ motion to dismiss in March 2018, the appeal was heard on 8 May 2019, and the Fed Cir decision handed down on 29 July 2019.

Federal Court affirms District Court finding Sandoz does not infringe Amgen’s ‘837 patent.

Sandoz announces resubmission of its BLA for pegfilgrastim biosimilar candidate, including new data from pharmacokinetics and pharmacodynamics studies.