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2024
Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The on-body injector utilises LTS Lohmann Therapie-Systeme AG’s wearable drug delivery platform.
Udenyca OnBody® received FDA approval in December 2023.
2023
Coherus Biosciences announced it received FDA approval for Udenyca OnBody® the on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. Commercial availability is planned for Q1 2024.
Coherus resubmitted its Biologics License Application (BLA) supplement for Udenyca OnBody® to the FDA in October 2023, following a satisfactory resolution of inspection findings at a third-party filler. The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.
CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.
CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars). There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.
CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®. CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon Biologics’ Ogivri®.
A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “can be used as safely as their respective reference biologics” based on real-world experience of all eight marketed products. The study summarised post-approval cumulative patient exposure and safety experience for the eight products based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding PSUR assessment reports authored by health authorities, where available, as of 31 January 2023. The authors also concluded that “it is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)”.
Coherus BioSciences announced it has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) to the FDA, following a satisfactory resolution of inspection findings at a third-party filler. The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.
On 4 October 2023, Coherus announced its sales of Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis® surpassed 100,000 doses in its first year.
Coherus Biosciences announced that the FDA issued a Complete Response Letter (CRL) for its BLA for Udenyca® OnBody™, Coherus’ on-body injector presentation of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim). The letter relates to an ongoing review of inspection findings at a third-party filler. The FDA did not identify issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing.
Separately, on 8 September 2023, Coherus announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.
Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s Neulasta® (pegfilgrastim). The withdrawal was made after guidance was received from EMA, which advised the Company it will not obtain EU-GMP certification of its biosimilars manufacturing facility within the current Day 180 clock stop period, which would not be extended. CuraTeQ confirmed it will work with the EMA to re-submit the applications as soon as possible.
On 11 January 2022, Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe.
Coherus BioSciences announced that its single-dose prefilled autoinjector of UDENYCA® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®, is now available in the US. UDENYCA® is administered after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
The FDA approved Udenyca® as a single-dose, prefilled autoinjector in March 2023.
Amneal announced it has launched FLYNETRA™ (pegfilgrastim) in the US, biosimilar to Amgen’s Neulasta®. FLYNETRA™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.
FLYNETRA™ was approved by the FDA in May 2022. This is Amneal’s third biosimilar approved in the US (following its filgrastim and bevacizumab biosimilars).
Coherus announced that the FDA has approved its single-dose, prefilled autoinjector presentation of Udenyca® (pegfilgrastim-cbqv) biosimilar to Amgen’s pegfilgrastim (Neulasta®) as an additional presentation on 3 March 2023. This the only US approved PFS presentation of pegfilgrastim.
Fresenius Kabi launched Stimufend® (biosimilar to Amgen’s Neulasta® pegfilgrastim) in the US. Stimufend is Fresenius Kabi’s first biosimilar launch in the US. Fresenius Kabi also intends to launch Idacio® (biosimilar to AbbVie’s Humira® adalimumab) in the US in July 2023 pursuant to its settlement agreement with AbbVie.
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.
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.
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 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.
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 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 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 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
Lupin and Biomm announced that they have entered into an exclusive distribution and marketing agreement for biosimilar pegfilgrastim in Brazil.
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 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.
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).
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 reported its Q1 2021 financial results. Biocon reported its biosimilars revenues from its subsidiary Biocon Biologics increased 53% year-on-year. Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.
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.
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.
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).
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 subsidiary Biocon Biologics’ new manufacturing facility in Bengalaru.
Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.
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.
Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.
Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.
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 pegfilgrastim biosimilar, Pelmeg®, in Europe. Pelmeg® was developed by Cinfa Biotech, and is the fourth biosimilar commercialised by Mundipharma.
Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.
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).
EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.
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.
Munidpharma acquires Cinfa Biotech, gaining immediate access to pegfilgrastim biosimilar and a platform to potentially develop more biosimilars in the future.
Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.
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 subsidiary Accord Healthcare will release pegfilgrastim biosimilar across Europe after receiving a positive response from the Committee for Medicinal Products for Human Use.
Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.
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.
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 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 announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.
Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.
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
Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.
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.
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.
FDA issues Complete Response Letter for Biocon’s pegfilgrastim. FDA has completed its review, but requires further CMC data.
FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.
Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).
Sandoz indicates it plans to conduct further studies with a target of 2018 for further submissions to the FDA.
Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is “working with the agency to address remaining questions.”
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
BioBlast® Editor and Contributing Author
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