BioBlast® - Search
FDA approves Amneal’s Fylnetra™ (biosimilar pegfilgrastim)
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.
Amgen and Pfizer settle pegfilgrastim dispute
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.
FDA approves Amneal’s Releuko™ (biosimilar filgrastim)
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.
Coherus BioSciences publishes its Q4 2021 financial results
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.
Lupin and Axantia Holding announce pegfilgrastim deal
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.
Amneal to acquire Saol’s Baclofen franchise
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.
Lupin and Biomm enter into pegfilgrastim agreement for Brazil
Lupin and Biomm announced that they have entered into an exclusive distribution and marketing agreement for biosimilar pegfilgrastim in Brazil.
Fresenius Kabi expecting to launch pegfilgrastim biosimilar in the EU in 2022
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.
Coherus Biosciences announces positive results from study of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device
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.
CuraTeQ submits MAA to EMA for proposed biosimilar pegfilgrastim
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).
Amgen warned by FDA over Neulasta® claims
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.
Biocon reports its Q1 2021 financial results
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.
Coherus reports Q420 and Full Year 2020 financial results
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.
AU | BR | EU | US |
Fresenius Kabi announces it will launch its biosimilar adalimumab in Australia in Q2 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.
US District Court refuses to award costs in pegfilgrastim dispute
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.
EMA approves Nyvepria®
The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).
Sandoz Canada enters agreement with pCPA for Ziextenzo® and Riximyo®
Pfizer Q2 FY20 financial results released
Pfizer releases its Q2 FY20 financial results. Pfizer reveals that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.
Results of study into Sandoz’s Ziextenzo® released
A new study published by the Journal of Clinical Pathways demonstrates significant cost-savings generated by Sandoz’s pegfilgrastim biosimilar Ziextenzo®.
Sandoz anticipates launch of pegfilgrastim and rituximab
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.
FDA approves Pfizer’s Nyvepria®
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.
Health Canada grants marketing approval for Ziextenzo® and Riximyo®
Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).
Sandoz granted marketing approval for Ziextenzo® and Riximyo®
Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).
FDA accepts Fresenius Kabi BLA
Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.
Fulphila® launched by Mylan and Biocon in Canada
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® in Australia
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 for proposed pegfilgrastim biosimilar
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).
FDA approves Biocon’s sBLA
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 discounted Ziextenzo®
Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.
Sandoz’s Ziextenzo® approved
FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.
CHMP recommends marketing authorisation for Mundipharm’s pegfilgrastim
The CHMP adopts a positive opinion for Mundipharma’s pegfilgrastim candidate, recommending marketing authorisation be granted.
Ziextenzo® approved by Australia’s TGA
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 US District Court’s joint status report
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 announces non-infringement of Udencya®
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 regarding Sandoz v Amgen
Federal Court affirms District Court finding Sandoz does not infringe Amgen’s ‘837 patent.
Sandoz resubmits BLA for pegfilgrastim biosimilar candidate
Sandoz announces resubmission of its BLA for pegfilgrastim biosimilar candidate, including new data from pharmacokinetics and pharmacodynamics studies.
Napp launches Pelmeg®
Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.
Apotex launches Lapelga®
Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.
Sandoz files suit against 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.
Mundipharma launches Pelmeg®
Mundipharma launches pegfilgrastim biosimilar, Pelmeg®, in Europe. Pelmeg® was developed by Cinfa Biotech, and is the fourth biosimilar commercialised by Mundipharma.
Launch of Udencya® announced by Coherus
Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.
Amgen’s Neulasta® and Ristempa® brands declared equivalent for substitution
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).
Sandoz approves Ziextenzo® for market
Sandoz announces EC marketing approval for pegfilgrastim biosimilar Ziextenzo®.
EMA approves Pelmeg® for treatment
EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.
Coherus discloses discounted biosimilar Udencya®
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.
Coherus’ biosimilar pegfilgrastim Udencya® approved
Munidpharma acquires Cinfa Biotech
Munidpharma acquires Cinfa Biotech, gaining immediate access to pegfilgrastim biosimilar and a platform to potentially develop more biosimilars in the future.
EU | US |
Results of clinical trials for Neulasta® biosimilar released
Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.
Third case against Apotex filed for biosimilars of Neupogen® and Neulasta®
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.
Intas announces release by Accord Healthcare
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.
CHMP releases a positive response to Coherus
Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.
FDA approves Mylan/Biocon’s Fulphila®
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.
Apotex’s Lapelga® is approved
Apotex achieves world first approval of pegfilgrastim biosimilar (Lapelga®) in Canada.
EU | US |
Coherus releases Q1/2018 results and expectations
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.
Coherus’ resubmission of BLA
Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701
Judge Stark dismissed with prejudice against Amgen
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.
Cadila plans an aBLA for biosimilar pegfilgastim
Cadila announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.
Celltrion announces potential pembrolizumab biosimilar
Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.
Refiling of MA for pegfilgrastim announced
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.
Cinfa Biotech anticipates further clinical data
Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.
Pfenex announces ceased development of PF582
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.
EU application for biosimilar pegfilgrastim accepted
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.
Complete Response Letter for Biocon’s pegfilgrastim released
FDA issues Complete Response Letter for Biocon’s pegfilgrastim. FDA has completed its review, but requires further CMC data.
Cinfa Biotech’s application for B12019 accepted
EMA accepts Cinfa Biotech’s application for B12019, biosimilar pegfilgrastim.
FDA releases Response letter for CHS-1701
FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.
Results from second clinical study for biosimilar pegfilgrastim announced
Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).
Sandoz’s EU application withdrawn
Sandoz withdraws EU application for Zioxtenzo, biosimilar pegfilgrastim.
MA withdrawn for biosimilar pegfilgrastim
Gedeon Richter announces withdrawal of its MA for biosimilar pegfilgrastim.
Sandoz plans further research
Sandoz indicates it plans to conduct further studies with a target of 2018 for further submissions to the FDA.
Coherus BioSciences filing for pegfilgrastim accepted
FDA accepts Coherus BioSciences 351(k) filing for pegfilgrastim.
Mylan/Biocon application on review
EMA accepts Mylan/Biocon application for biosimilar pegfilgrastm for review.
Application for Zioxtenzo® rejected
FDA rejects Sandoz’s application for Zioxtenzo®, biosimilar pegfilgrastim.
FDA releases a response to Zioxtenzo
Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is “working with the agency to address remaining questions.”
Filing for Zioxtenzo accepted
EMA accepts Sandoz’s filing for Zioxtenzo, biosimilar pegfilgrastim.
Application for biosimilar Neulasta accepted
FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
Get our Pearce IP Blogs & BioBlast® sent directly to your inbox
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.