Neulasta® | Pegfilgrastim | Amgen

August 18, 2020

19 Aug 20 | CA | Sandoz | 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. 

 

28 Jul 2020 | US | Pfizer | Pfizer releases its Q2 FY20 financial results. Pfizer reveals that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.

 

24 Jul 2020 | All | Sandoz | A new study published by the Journal of Clinical Pathways demonstrates significant cost-savings generated by Sandoz's pegfilgrastim biosimilar Ziextenzo®.

 

17 Jul 2020 | CA | Sandoz | In an interview with Generics Bulletin, Sandoz Canada announces it is aiming for 10 biosimilar launches in the next decade, with pegfilgrastim and rituximab to be launched shortly.

 

11 June 2020 | US | Pfizer | 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.

 

09 June 2020 | CA | Sandoz | Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

 

27 May 2020 | US | Fresenius Kabi | Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.

 

28 April 2020 | CA | Mylan, Biocon | 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.

 

14 Apr 2020 | AU | Mylan, Biocon | 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.

 

11 Feb 2020 | US | Amgen, Hospira | 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).​

 

27 Nov 2019 | US | Biocon | 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. 

 

15 Nov 2019 | US | Sandoz | Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.

 

05 Nov 2019 | US | Sandoz | FDA approves Sandoz's pegfilgrastim biosimilar Ziextenzo®.

 

17 Oct 2019 | EU | Mundipharma | The CHMP adopts a positive opinion for Mundipharma's pegfilgrastim candidate, recommending marketing authorisation be granted. 

 

06 Sep 2019 | AU | Sandoz | Australia's TGA approves Ziextenzo® in 6mg/0.6mL solution for injection prefilled syringe for the treatment of cancer patients following chemotherapy.

 

21 Aug 2019 | US | Amgen, Mylan | 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.

 

29 Jul 2019 | US | Coherus | 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.

 

08 May 2019 | US | Amgen, Sandoz | Federal Court affirms District Court finding Sandoz does not infringe Amgen's '837 patent.

 

03 Apr 2019 | US | Sandoz | Sandoz announces resubmission of its BLA for pegfilgrastim biosimilar candidate, including new data from pharmacokinetics and pharmacodynamics studies.

 

01 Mar 2019 | UK | Napp Pharmaceuticals | Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.

 

28 Feb 2019 | CA | Apotex | Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada. 

 

26 Feb 2019 | US | Sandoz, Amgen | 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.

 

05 Feb 2019 | EU | Mundipharma | Mundipharma launches pegfilgrastim biosimilar, Pelmeg®, in Europe.  Pelmeg® was developed by Cinfa Biotech, and is the fourth biosimilar commercialised by Mundipharma.

 

04 Jan 2019 | US | Coherus | Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.

 

14 Dec 2018 | AU | Mylan/Alphapharm | 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). 

 

27 Nov 2018 | EU | Sandoz | Sandoz announces EC marketing approval for pegfilgrastim biosimilar Ziextenzo®.  

 

20 Nov 2018 | US | Mundipharma | EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.

 

08 Nov 2018 | US | Coherus | 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.

 

02 Nov 2018 | US | Coherus | FDA approves Coherus' biosimilar pegfilgrastim Udencya® for patients receiving myelosuppressive chemotherapy.   This is the first US/EU approved biosimilar approved for this indication.

 

9 Oct 2018 | EU US | Fresenius Kabi | Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.

 

7 Aug 2018 | US | Apotex | 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.

 

30 Jul 2018 | EU | Intas Pharmaceuticals | 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.

 

27 Jul 2018 | EU | Coherus | Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.

 

04 Jul 2018 | EU | Biocon | Biocon receives EU CGMP certification for its facility in Bangalore, clearing the way for the approval of pegfilgrastim and trastuzumab biosimilars.

 

4 Jun 2018 | US | Mylan/Biocon | 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.

 

1 Jun 2018 | CA | Apotex | Apotex achieves world first approval of pegfilgrastim biosimilar (Lapelga®) in Canada.

 

10 May 2018 | EU/US | Coherus Biosciences | 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.

 

03 May 2018 | US | Coherus BioSciences | Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701

 

26 Mar 2018 | US | Coherus BioSciences | 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.

 

01 Mar 2018 | US | Cadila Healthcare | Cadila announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.

 

03 Feb 2018 | EU | Stada/ Gedeon Richter | 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.

 

09 Nov 2017 | All | Pfenex | 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. Read more

 

07 Nov 2017 | EU | Mylan/Biocon | Mylan refiles EU applications for biosimilar pegfilgrastim and trastuzumab.  Read more

 

02 Nov 2017 | All | Cinfa Biotech | Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.  Read more

 

27 Oct 2017 | EU | Sandoz | 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 2017Read more 

 

10 Oct 2017 | US | Mylan/Biocon | FDA issues Complete Response Letter for Biocon's pegfilgrastim.  FDA has completed its review, but requires further CMC data.  Read more

 

04 Oct 2017 | EU | Cinfa Biotech | EMA accepts Cinfa Biotech's application for B12019, biosimilar pegfilgrastim.  Read more

 

16 Aug 2017 | EU | Mylan/Biocon | Mylan/Biocon withdraw EU applications for trastuzumab & pegfilgrastim.  Read more 

12 Jun 2017 | US | Coherus Biosciences | FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701. Read more  

17 May 2017 | All | Cinfa Biotech | Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).  Read more

27 Jan 2017 | EU | Sandoz |  Sandoz withdraws EU application for Zioxtenzo, biosimilar pegfilgrastim.  Read more

19 Dec 2016 | EU| Gedeon Richter | Gedeon Richter announces withdrawal of its MA for biosimilar pegfilgrastim

 

25 Oct 2016 | US | Sandoz |  Sandoz indicates it plans to conduct further studies with a target of 2018 for further submissions to the FDA.  Read more

06 Oct 2016 | US | Coherus BioSciences | FDA accepts Coherus BioSciences 351(k) filing for pegfilgrastim.  Read more

Jul 2016 | US | Sandoz | FDA rejects Sandoz’s application for Zioxtenzo, biosimilar pegfilgrastim.  Read more

21 Jul 2016 | EU | Mylan/Biocon | EMA accepts Mylan/Biocon application for biosimilar pegfilgrastm for review. Read more 

 

19 Jul 2016 | US | Sandoz | Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is "working with the agency to address remaining questions."  Read more

11 Feb 2016 | EU | Sandoz | EMA accepts Sandoz’s filing for Zioxtenzo, biosimilar pegfilgrastim. Read more

12 Dec 2014 | US | Apotex/Intas | FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.  Read more

 

 

 

 

 

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Biosimilars Bulletin 

November 9, 2020

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