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2023
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)”.
An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar. Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.
On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.
Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s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.
A study published in Health Affairs has suggested the US 340B Drug Pricing Program has reduced biosimilar uptake in hospitals that participate in the Program. The 340B Program offers eligible safety-net hospitals (almost one third of US hospitals) to purchase originator medicines at a significant discount. The authors analysed figures on filgrastim and infliximab and estimated that 340B program eligibility was associated with a 22.9% reduction in biosimilar adoption.
The research was sponsored by the Commonwealth Fund.
2022
Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019. This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (biosimilar bevacizumab) in October 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.
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
Amgen and Hospira appear ready to settle the ongoing dispute relating to Neupogen® (filgrastim). The matter was due to go to a jury trial on 20 September 2021.
2020
Onco’Zine reports a new study released by the American Society of Clinical Oncology Quality Care Symposium indicates that Sandoz’s Zarxio® (biosimilar filgrastim) is not only safe and effective, but is cost effective in treating chemotherapy-induced febrile neutropenia in early-stage breast cancer patients.
The US District Court of Delaware refuses to combine Amgen’s two actions against Pfizer and Hospira relating to filgrastim. The original action was filed in July 2018, and the more recent action was filed in April 2020. In the oral order, (available courtesy of Goodwin), the Court ruled that as Amgen would not agree to use the same experts for both cases, they should bear the consequences of litigating an action nearly two years after the original action. The Court also indicated that it would entertain Pfizer/Hospira’s proposed motion to stay the second action.
Amgen filed suit against Hospira and Pfizer, alleging infringement of US patent 10,577,392, relating to the manufacture of Neupogen®. Interestingly, the patent was only granted on March 03, 2020, nearly 2 years after Hospira launched Nivestym®.
New study demonstrates noninferiority of Pfizer’s Nivestim® to reference Neupogen®. Additionally, the study demonstrated that those in the biosimilar group reported a shorter median hospitalisation period by two days.
2019
Amgen and Tanvex file a joint stipulation of dismissal in their filgrastim dispute. The stipulation of dismissal states that parties will bear their own costs and attorney’s fees.
A new study released by the Universities of Saskatchewan and Alberta reveal substantial savings for health services switching to Apotex’s Grastofil®. The study analysed Canadian sales between 2016 and 2018, finding that the biosimilar accounted for $13,443,873 in savings, but could have accounted for $36,348,476 in savings had it been used in 100% of cases.
Amneal and Amgen settle patent dispute over filgrastim biosimilar. Notice of the settlement was approved by a US Federal Court, however no further details have been published. Amgen had filed the complaint against Amneal in March 2018, alleging infringement of a number of patents.
FDA issues a complete response letter for Tanvex’s proposed filgrastim biosimilar. Tanvex has announced that the FDA did not request additional clinical data or express concern related to product safety, but that certain items needed to be addressed before the application could be approved.
Amgen files new patent infringement suit against Tanvex. Amgen’s complaint alleges that Tanvex did not provide certain manufacturing information required by BPCIA legislation.
Study reveals outcomes for the use of filgrastim in stem cell mobilisation prior to transplant, recording similar outcomes for tbo-filgrastim, the reference drug and biosimilar filgrastim (Zarxio).
Federal Court affirms District Court finding Sandoz did not infringe Amgen’s ‘837 patent.
2018
Tanvex announces that the FDA has accepted its BLA for biosimilar filgrastim.
US |
Zarxio® recognition
Sandoz’s biosimilar Zarxio® is included in Express Script’s 2018 National Preferred Formulary.
Significant increase in the use of alternative filgrastim products reported among Medicare Part B beneficiaries.
Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). The patent under scrutiny, US Patent No. 9,856,287 was issued on 2 January this year and therefore was not included in earlier ‘patent dances’ claiming priority to the original ‘138 patent. With three additional pending patent applications claiming priority to the ‘138 patent, it is likely that further litigation will result.
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.
Teva launches first biosimilar filgrastim in South Africa at 70% of the price of Amgen’s product. This comes more than 5 years after Teva first sought regulatory approval, demonstrating the backlog of products awaiting approval from the South African Health Products Regulatory Authority.
Pfizer announces FDA approval of Pfizer’s Nivestym®, biosimilar to filgrastim for all indications.
2016
Biograstim’s withdrawal of marketing authority, declared by European Commission following voluntary withdrawal from CT Arzneimittel’s biosimilar representative Marketing-Authorisation holder (MAH).
Sandoz biosimilar Zarxio® approved for US sale with the same indications as Neupogen®, and with a “placeholder” name “figrastim-sndz”. This is the first approval of a biosimilar product in the US.
Canadian drug manufacturer Apotex announces FDA has accepted for filing its Biosimilar application for Filgrastim (Grastofil®) along side previous patent Neupogen® within the US Marketplace.
2014
US based manufacturer granted approval from EMA to distribute filgrastim biosimilar Accofil®.
2013
EMA welcomes Apotex’s biosimilar Filgrastim rendition, Grastofil®, throughout Europe.
2011
European Commission (EC) withdraws EU marketing authorisation following Filgrastim Ratiopharm® MAH’s voluntary withdrawal.
2010
A Biosimilar product of Filgrastim was approved by the European Commission and marketed across several European countries under the name of Nivestim®.
2009
Sandoz’ EP2006 was approved by EMA for marketing in the European Union (EU) under the trade name Zarzio® as a biosimilar product to EU-approved Neupogen®.
2008
In accordance to the 2014 European Public Assessment Report (EPAR) Certified by EMA, Ratiopharm marketed a biological medicine in late 2008 known as Ratiograstin®. This medicine is a biosimilar to the previously pattened EU authorised Filgrastim (Neupogen®).
The European Commission’s Directorate General for Enterprise and Industry granted Teva a Marketing Authorization for its human G-CSF product, Tevagrastim®.
New filgrastim drug Biograstim® given the green light for market authorisation and distribution by European Commission (EC) and EMA.
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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