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Scientific Name: pegfilgrastim

2022

September 1, 2022

The FDA approved Fresenius Kabi’s Stimufend® (biosimilar pegfilgrastim).  Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

August 19, 2022

AU’s TGA approved Cipla’s FILPEGLA® (biosimilar pegfilgrastim) for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

May 27, 2022

Amneal Pharmaceuticals announced that the FDA has approved its ABLA for Fylnetra™ (biosimilar pegfilgrastim).  Fylnetra™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.  This is Amneal’s third biosimilar approved in the USA (following its filgrastim and bevacizumab biosimilars), which was developed in collaboration with Chicago based Kashiv Biosciences.

March 19, 2022

Amgen and Pfizer settled their pegfilgrastim (Neulasta®) dispute Amgen Inc v Hospira Inc (D. Del., No. 20-201) which has been on foot since February 2020.  No further details about the settlement agreement have been published to date.

March 1, 2022

Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021).  Amneal also disclosed that US applications for biosimilar pegfilgrastim and bevacizumab are under FDA review, and Amneal plans to launch both products in 2022.

February 17, 2022

Coherus BioSciences published its Q4 2021 financial results, reporting a net loss of $45.7 million.  Coherus attributed this net loss to a decrease in the number of units of Udenyca® (biosimilar pegfilgrastim) sold, as well as a decline in net realised price due to increased competition and COVID-19 impacts.

February 1, 2022

Lupin announced that it has entered into a license, supply and technology sharing agreement with Axantia Holding for biosimilar pegfilgrastim in certain territories, including Saudi Arabia, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.

January 5, 2022

Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise.  This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.

2021

December 3, 2021

Lupin and Biomm announced that they have entered into an exclusive distribution and marketing agreement for biosimilar pegfilgrastim in Brazil.

November 2, 2021

Fresenius Kabi released its Q3 2021 financial results. Fresenius Kabi confirmed that despite delays due to COVID-19, it expects to launch its pegfilgrastim biosimilar candidate in the EU in 2022.

October 5, 2021

Coherus Biosciences announced positive results from a randomised, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device compared to the currently marketed Udencya® pre-filled syringe. Coherus plans to submit its application to the FDA in 2022 and expects to launch directly post approval.

September 23, 2021

Business Standard reported that Aurobindo Pharma (through the subsidiary CuraTeQ Biologics) has submitted a Marketing Authorisation Application to the EMA for BP14 (proposed biosimilar pegfilgrastim).

July 14, 2021

The FDA notified Amgen of its concerns relating to potential false or misleading promotional communications about Neulasta® (pegfilgrastim). The FDA alleged that promotional materials released by Amgen made false or misleading claims and representations about the benefit of Neulasta® when administered through the Onpro injection compared to a prefilled syringe. Amgen must provide a written response within 15 working days from the date of receipt of the letter.

April 29, 2021

Biocon reported its Q1 2021 financial results.  Biocon reported its biosimilars revenues increased 53% year-on-year.  Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.

February 24, 2021

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.

February 23, 2021

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.

2020

December 1, 2020

US District Court Judge Leonard Stark refuses to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

November 18, 2020

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

August 19, 2020

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. 

July 28, 2020

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

July 24, 2020

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

July 17, 2020

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.

June 11, 2020

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.

June 9, 2020

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

June 9, 2020

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

May 27, 2020

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

April 28, 2020

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.

April 14, 2020

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.

February 11, 2020

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).​

2019

November 27, 2019

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.

November 16, 2019

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

November 5, 2019

FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

October 25, 2019

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

September 6, 2019

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

August 21, 2019

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.

July 29, 2019

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.

May 10, 2019

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

April 2, 2019

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

March 1, 2019

Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.

February 28, 2019

Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.

February 25, 2019

Sandoz files suit against Amgen, seeking DJ of non-infringement and invalidity. This comes as Sandoz awaits FDA decision on its pegfilgrastim biosimilar, with Sandoz hoping to block any preliminary injunction motions from Amgen.

February 5, 2019

Mundipharma launches pegfilgrastim biosimilar, Pelmeg®, in Europe. Pelmeg® was developed by Cinfa Biotech, and is the fourth biosimilar commercialised by Mundipharma.

January 5, 2019

Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.

2018

December 14, 2018

PBAC releases results from November PBAC meeting. The PBAC recommended Alphapharm’s Fulphila® for listing on the PBAC for all indications with “A” flagging.  Fulphila® and Amgen’s Neulasta® and Ristempa® brands of pegfilgrastim are now considered equivalent for the purpose of substitution (i.e. “A” flagged).

November 27, 2018

Sandoz announces EC marketing approval for pegfilgrastim biosimilar Ziextenzo®.

November 20, 2018

EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.

November 8, 2018

Coherus discloses newly approved biosimilar Udencya® will be available at a 33% discount to Neulasta®, matching the price point for Mylan’s biosimilar Fulphila®. The product is due to be launched on 3 January 2019.

November 2, 2018

FDA approves Coherus’ biosimilar pegfilgrastim Udencya® for patients receiving myelosuppressive chemotherapy. This is the first US/EU approved biosimilar approved for this indication.

October 10, 2018

Munidpharma acquires Cinfa Biotech, gaining immediate access to pegfilgrastim biosimilar and a platform to potentially develop more biosimilars in the future.

October 9, 2018

Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  US patent 9,856,287 was issued on 2 January 2018 and was not included in earlier ‘patent dances’.  With three additional pending patent applications in this family, it is likely that further litigation will result.

July 31, 2018

Intas announces subsidiary Accord Healthcare will release pegfilgrastim biosimilar across Europe after receiving a positive response from the Committee for Medicinal Products for Human Use.

July 27, 2018

Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.

June 4, 2018

FDA approves Mylan/Biocon’s pegfilgrastim (Fulphila®) on Mylan’s resubmitted application.  This is a the first US Neulasta® biosimilar approved; the second US biosimilar approved from the Mylan/Biocon portfolio; and the tenth US biosimilar overall.  See related FDA media release here.

June 1, 2018

Apotex achieves world first approval of pegfilgrastim biosimilar (Lapelga®) in Canada.

May 10, 2018

Coherus provides 2018 forecasts in its Q1/2018 results, including EU approval opinion by 28 June 2018, and US BLA acceptance by 3 June 2018. Commercial discussions ongoing.

May 3, 2018

Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701

March 26, 2018

Coherus announces that Judge Stark (US District Court for the District of Delaware) dismissed with prejudice Amgen’s patent infringement complaint alleging infringement of US8,273,707.

 

March 2, 2018

Cadila announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.

February 14, 2018

Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.

February 3, 2018

Gedeon Richter announces refiling of MA for pegfilgrastim, following the completion of further clinical trials. GR withdrew its previous application in Dec 2016.  See Stada subsequent announcement here.

2017

November 1, 2017

Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.

October 30, 2017

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.

October 27, 2017

Sandoz’s (refiled) EU application for biosimilar pegfilgrastim accepted for regulatory review by EMA. Sandoz received an FDA rejection in Jul 2016, and withdrew its earlier EMA application in Jan 2017.

October 10, 2017

FDA issues Complete Response Letter for Biocon’s pegfilgrastim. FDA has completed its review, but requires further CMC data.

October 4, 2017

EMA accepts Cinfa Biotech’s application for B12019, biosimilar pegfilgrastim.

June 12, 2017

FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.

May 17, 2017

Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).

January 27, 2017

Sandoz withdraws EU application for Zioxtenzo, biosimilar pegfilgrastim.

2016

December 19, 2016

Gedeon Richter announces withdrawal of its MA for biosimilar pegfilgrastim.

October 25, 2016

Sandoz indicates it plans to conduct further studies with a target of 2018 for further submissions to the FDA.

October 6, 2016

FDA accepts Coherus BioSciences 351(k) filing for pegfilgrastim.

July 21, 2016

EMA accepts Mylan/Biocon application for biosimilar pegfilgrastm for review.

July 20, 2016

FDA rejects Sandoz’s application for Zioxtenzo®, biosimilar pegfilgrastim.

July 19, 2016

Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is “working with the agency to address remaining questions.”

February 11, 2016

EMA accepts Sandoz’s filing for Zioxtenzo, biosimilar pegfilgrastim.

2015

January 5, 2015

FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.

BioBlast® extract From January 5, 2015 to September 1, 2022