BioBlast w/e 26 May 23

26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara^® (ustekinumab)

Korea Biomed has reported that Celltrion filed a marketing authorisation application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara^® (ustekinemab).  Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy, pharmacokinetic, and safety results between CT-P43 and Stelara^®, Celltrion’s MAA sought approval for all Stelara^® indications.  Celltrion confirmed it intends to seek approval in other key countries.

26 MAY 2023 | EU | FDA approves STADA-controlled Norbitec biologics facility to manufacture and store Pfizer’s Retacrit^® (epoetin alfa-epbx) biosimilar to Amgen’s Epogen^® /Procrit^®

The Pharma Letter has reported that the STADA-controlled Norbitec biologics facility in Uetersen, Germany, has been approved by the FDA to manufacture and store Pfizer’s Retacrit^® (epoetin alfa-epbx), biosimilar to Amgen’s Epogen^® /Procrit^®.  The approval followed a six-day FDA inspection of the German site.

25 MAY 2023 | US | FDA grants priority review of NDA for Takeda and HUTCHMED’s fruquintinib

Takeda and HUTCHMED announced that the FDA granted priority review for the NDA of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, for the treatment of previously treated metastatic colorectal cancer.  The Prescription Drug User Fee Act goal date for the FDA’s decision is set for 30 November 2023.  The NDA submission includes data from the Phase 3 FRESCO-2 trial, which demonstrated significant improvements in overall survival and progression-free survival.  Fruquintinib is currently approved in China under the brand name ELUNATE^®.

25 MAY 2023 | EU | EMA accepts MAAs for Sandoz’s denosumab biosimilars to Amgen’s Prolia^® and Xgeva^®

Sandoz announced that the European Medicines Agency (EMA) has accepted marketing authorisation applications (MAA) for its proposed biosimilar denosumab, for regulatory review.  The two applications include the approved indications for the originator drugs Prolia^® and Xgeva^®, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.

This week Mitsubishi and GlycoNex announced Japanese approval of their phase I clinical trial of SPD8, a denosumab biosimilar to Prolia^®.

24 MAY 2023 | US | Amgen provides further details on Stelara® settlement with Janssen

As previously reported, on 22 May 2023 the US District Court of Delaware dismissed Janssen’s patent infringement case against Amgen pertaining to its Stelara^® (ustekinumab) biosimilar with prejudice on the basis that each party bears its own costs. The proposed orders made it clear that the parties had settled.

Reuters has since reported a statement by Amgen that the ustekinumab settlement will permit Amgen to sell its biosimilar “no later than January 1^st, 2025”, suggesting the permitted launch date may be earlier than 1 January 2025.  As the API patent, one of six patents Janssen asserted in the proceedings, expires on 25 September 2023, we speculate that the agreed launch date is some time between 25 September 2023 and 1 January 2025.

24 MAY 2023 | US | Approval alert: FDA approves Celltrion’s Yuflyma^® (adalimumab) biosimilar to AbbVie’s Humira^®

Celltrion announced that its Yuflyma^® (adalimumab) product, a high-concentration formulation and biosimilar to AbbVie’s Humira^®, has obtained FDA approval.  According to Celltrion, Yuflyma^® will be available in the US from July for the key indications of Humira^®, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.

Celltrion’s announcement came only three days after Boehringer Ingelheim announced its Humira® biosimilar Cyltezo^® autoinjector pen obtained FDA approval.

23 MAY 2023 | JP | PMDA approves Mitsubishi and GlycoNex’s phase I clinical trial for denosumab biosimilar to Amgen’s Prolia®

Mitsubishi Gas Chemical Company, Inc. and GlycoNex announced approval to commence a phase I clinical trial of SPD8 denosumab, biosimilar to Amgen’s Prolia^®, from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).  The companies announced that the first patient has now been enrolled.  The double-blind trial will compare SPD8 with Prolia^® in healthy postmenopausal women, who will undergo pharmacokinetic and safety assessments.

This month Boan Biotech commenced its phase III clinical trial for its Prolia^® denosumab biosimilar.

23 MAY 2023 | UK | NICE recommends combination of Merck’s Keytruda^® (pembrolizumab) and Eisai’s Lenvima^® (lenvatinib) for endometrial cancer

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending Merck’s Keytruda^® (pembrolizumab) combined with Eisai’s Lenvima^® (lenvatinib) as an option for treating advanced or recurrent endometrial cancer in adults whose cancer has progressed on or after platinum-based chemotherapy who cannot have curative surgery or radiotherapy, in the NHS in England and Wales.

In March 2023, NICE recommended the use of Keytruda^® for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.

23 MAY 2023 | US | Amgen files motion to intervene in aflibercept proceedings

Amgen filed a motion to intervene in the proceedings on foot between Regeneron and Mylan in West Virginia relating to aflibercept, and has sought to unseal certain documents. Amgen argued that the sealing of the documents blocked the public’s right of access to Court documents, and that the Court has provided no justification for sealing a number of documents.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

22 MAY 2023 | EU | Alvotech enters supply agreement with Advanz for five biosimilars including golimumab and vedolizumab in EU, UK and CH following Stada termination

Alvotech announced that it has entered into a master license and supply agreement with Advanz to commercialise and supply in Europe AVT05 (biosimilar to Janssen’s Simponi^® and Simponi Aria^® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio^® (vedolizumab)), and three additional early-stage, undisclosed biosimilar candidates.

Under this agreement:

• Alvotech will develop the products and provide the dossiers.
• Advanz has an exclusive right to obtain and maintain regulatory approvals for the products and to commercialize them in the European Economic Area, the United Kingdom and Switzerland
• Advanz will make upfront payments of €56M
• Advanz will make additional milestone payments for an aggregate amount of up to €264
• Alvotech will manufacture, supply and deliver the product to Advanz
• Advanz will exclusively buy the relevant biosimilar candidate from Alvotech at a royalty of approximately 40% of the estimated net selling price or an agreed-upon floor price

On 19 May 2023, Alvotech and STADA entered into three termination agreements to terminate the license and supply agreements between Alvotech and STADA pertaining to Alvotech’s product candidates AVT03 (biosimilar candidate to Prolia®/Xgeva® (denosumab)), AVT05 and AVT16.  Alvotech will repay €17.4M it received from STADA under the (now terminated) agreement.

On 19 May 2023, Alvotech also disclosed the reference products for two product candidates in its pipeline: AVT16 (above) and the reference product for AVT33 is Merck’s Keytruda^® (pembrolizumab).

This comes after Alvotech announced in February 2023 that it entered an exclusive agreement with Advanz Pharma regarding   for EU, UK CA, CH and ANZ.

22 MAY 2023 | BR | Celltrion launches Remsima^® SC (infliximab) biobetter in Brazil

The Korea Herald has reported that Celltrion has launched its Remsima^® SC (infliximab, bio-better to Janssen’s Remicade®) in Brazil, the largest pharmaceutical market in South America.  Celltrion is also selling Remsima^® and Truxima^® (rituximab, biosimilar to Biogen’s Rituxan^® ) in Brazil and plans to introduce Remsima SC in Mexico, Colombia and Peru during the second half of 2023.

Celltrion recently presented its positive phase III results for Remsima® SC as a sub-cutaneous maintenance therapy for IBD patients.

22 MAY 2023 | US | Coherus announces UDENYCA^® (pegfilgrastim) autoinjector launch in the US

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.

21 MAY 2023 | US | Approval alert: FDA approves Boehringer’s Cyltezo^® (adalimumab) autoinjector pen

Boehringer Ingelheim announced that the FDA has approved an autoinjector pen presentation of its Cyltezo^® (adalimumab-adbm), an FDA-approved interchangeable biosimilar to AbbVie’s Humira^® (adalimumab). Cyltezo^® is indicated for multiple chronic inflammatory diseases.  The autoinjector pens will be available in the US from 1 July 2023.

Boehringer is licensed to supply its adalimumab biosimilar in the US from 1 July 2023.  In total, AbbVie entered into numerous deals with biosimilar entrants enabling US market entry as follows: Samsung Bioepis/Merck (30 June 2023),  Alvotech (1 July 2023), Coherus (1 July 2023),  Celltrion (July 2023),  Fresenius Kabi (July 2023),  Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), and Pfizer (20 November 2023).

21 MAY 2023 | UK | Eisai submits MAA in UK for LEQEMBI^® (lecanemab) for early Alzheimer’s

Biogen and Eisai announced that Eisai submitted a marketing authorisation application (MAA) for LEQEMBI^® (lecanemab) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).  LEQEMBI^® is an investigational anti-amyloid beta protofibril antibody indicated for the treatment of early Alzheimer’s disease (AD) with confirmed amyloid pathology in the brain.  Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway.

Last week Health Canada accepted a new drug submission for LEQEMBI^® to treat early AD and mild AD dementia with confirmed amyloid pathology in the brain.

15 MAY 2023 | CN | Boan completes patient enrolment for phase III study for biosimilar to Lilly’s Trulicity^® (dulaglutide)

Boan Biotech announced that it has completed patient enrolment in its phase III clinical trial for BA5101, its proposed biosimilar to Eli Lilly’s Trulicity^® (dulaglutide) used in patients with insufficiently controlled type 2 diabetes mellitus.  Boan’s clinical trial will compare the clinical efficacy, safety, immunogenicity and pharmacokinetics of BA5101 with Trulicity^® in Chinese adult patients with type 2 diabetes.

Two weeks ago, Boan’s parent company Luye Pharma announced that it commenced a phase III clinical trial for its Prolia^®/Xgeva^® (denosumab) biosimilar.

26 APR 2023 | US | Regeneron adds further patents to Purple Book patent list

Regeneron listed additional aflibercept patents on the Purple Book patent list. The Purple Book patent list records the patents exchanged between the originator and biosimilar applicant as part of the “patent dance” and suggests that another dance has begun with a second biosimilar applicant. There are now 46 aflibercept patents listed on the Purple Book, including the 24 asserted against Mylan in August 2022.