Pearce IP BioBlast w/e 05 Jan 2024

The Korea Biomedical Review has reported that Celltrion confirmed it has increased Australian sales of Remsima SC®, biobetter to Remsima® (IV product), biosimilar to Janssen’s Remicade® (infliximab), in the first nine months of 2023 by 48% year on year.  Celltrion expects Remsima SC® to generate annual sales in Australia of more than AUD$17M in 2023.  Remsima SC® was approved by the TGA on 12 November 2020.

AGC Biologics announced that it will construct a new manufacturing facility for biologics and advanced therapy medicinal products (ATMPs) in Yokohama Japan.  It expects the site to be operational in 2026.

The 20,000 m² facility will offer pre-clinical through to commercial services for mammalian-based protein biologics, messenger RNA (mRNA) and cell therapy services.

In 2021, AGC Biologics and Xbrane Biopharma entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.

Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®.

DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021.  Accord BioPharma will be responsible for US commercialisation.

In the same announcement, Accord announced that in October 2023 it reached a settlement with Janssen that would allow Accord to launch DMB-3115 in the US no later than 15 May 2025, pending FDA approval.

Glenmark Pharmaceuticals announced it has launched Lirafit®, the biosimilar to Novo Nordisk’s Victoza®/Saxenda® (liraglutide) in India.  Liralift® is priced at around INR100 for a standard dose (~AUD$1.80), a 70% price reduction compared to the originator product.  Lirafit® is indicated for improving glycaemic control in adult patients with type 2 diabetes mellitus.

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents.  The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA)  for SB12, its biosimilar to Alexion’s Soliris® (eculizumab), accepted by the US Food and Drug Administration (FDA) on 7 July 2023.  Soliris® is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and other conditions.  On 7 July 2023, Samsung provided its 180-day notice of commercial marketing to Alexion.

In August 2023, Amgen appealed Alexion’s successful preliminary injunction order regarding Amgen’s off-label use of its eculizumab biosimilar Bekemv® in Germany.

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept).   The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea® in patients with neovascular (wet) age-related macular degeneration.  The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT06 and Eylea®.

In May 2023, Alvotech and Polifarma announced an exclusive commercialisation agreement for AVT06 in Turkey.

Coherus Biosciences announced that it has launched Loqtorzi® (toripalimab-tpzi) in the US.  It was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine to treat adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

AstraZeneca and Sanofi announced that Beyfortus® (nirsevimab) has been approved by the National Medical Products Administration (NMPA) in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.  The companies anticipate Beyfortus® will be available during the upcoming 2024-2025 RSV season.  Beyfortus® is the first approved preventive option to protect against RSV in a broad infant population.

The FDA approved Beyfortus® for the same indication and to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season on 17 July 2023.

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has confirmed its submission is complete for its marketing authorisation (MA) for repotrectinib.  BMS is seeking approval of repotrectinib as a treatment for ROS1 TKI-naïve and pre-treated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pre-treated adult and paediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumours.

On 15 November 2023 the FDA approved BMS’s Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new International Recognition Procedure (IRP), allowing medicine developers to now submit applications.  The IRP replaces the EC Decision Reliance Procedure after the UK left the EU in 2016, and allows the MHRA to take into account the expertise of trusted regulatory partners in other countries when authorising medicines.  The MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the European Economic Area.

Judge Thomas Kleeh of the US District Court for the Northern District of West Virginia has found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents.  The Court published a short form judgment and concluded that:

• Mylan infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of the formulation patent no. 11,084,865;
• Mylan would induce infringement of claims 6 and 25 of method of treatment patent no. 11,253,572 and claims 11 and 19 of patent no. 10,888,601;
• the relevant claims of ‘865 were valid (Mylan’s arguments they were invalid for lack of novelty, inventive step, written description, enablement or indefiniteness failed);
• claims 6 and 25 of ‘572 and claims 11 and 19 of ‘601 lacked inventive step.

The valid ‘865 patent expires in the US on 14 June 2027.  Detailed reasons for the findings are under seal.  Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®. On 27 April 2023, Regeneron filed a stipulation to narrow the case to the above three patents. Regeneron’s Complaint asserts that the FDA notified Mylan of acceptance of its aBLA on 28 December 2021.

Formycon announced that the European Medicines Agency (EMA) accepted its marketing authorisation application (MAA) for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

On 29 November 2023, Regeneron sued Formycon in the US for infringement of 39 of its Eylea® patents.

The Korea Biomedical Review reported that Celltrion has submitted its marketing authorisation application for CT-P39, its biosimilar to Xolair® (omalizumab) to Health Canada.  The application includes all Xolair® indications, including allergic asthma, chronic rhinosinusitis and chronic urticaria.

Celltrion applied for European marketing authorisation for CT-P39 in April 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.

Celltrion announced in a corporate filing that its phase III clinical trial demonstrated that CT-P17, biosimilar to AbbVie’s Humira® (adalimumab), is interchangeable with Humira® in patients with plaque psoriasis.  Celltrion plans to apply to the FDA for interchangeability status in the US.

Nikkei Asia reported that Eisai will apply to the FDA to expand the approval Leqembi® (lecanemab) to use for prevention of Alzheimer’s disease (AD) as soon as April 2026.  Clinical trials are in the final stages.  Leqembi® was co-developed by Eisai and Biogen.

Leqembi® was approved in Japan on 25 September 2023 and received traditional approval in the US to treat AD on 6 July 2023.

Biocon Biologics announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan.

Biocon Biologics acquired the global biosimilars portfolio of Viatris with a deal signed in November 2022.  It completed integration in Europe in November 2023, and in North America in September 2023.  The most recent announcement states that Viatris will continue to provide transition support until Sandoz assumes responsibility for the product from 15 February 2024.

Daiichi Sankyo and Merck announced that the FDA has accepted for priority review its Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date for its regulatory decision of 26 June 2024.

Johnson & Johnson announced it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of Rybrevant® (amivantamab) combined with lazertinib, as a first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.

The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent.  The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings IPR2023-01069 and IPR2023-01070 respectively.  The patents cover method of treatment claims in treating paroxysmal nocturnal hemoglobinuria (PNH).

On 8 December 2023, PTAB instituted three other Samsung Bioepis petitions against Alexion’s Soliris® patent: US patent nos. 9,725,504, 9,718,880 and 9,732,149.  Samsung Bioepis launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023.  Epysqli® was approved by the EMA on 30 May 2023.

The Business Standard reported that AstraZeneca Pharma India said it will launch Enhertu® (trastuzumab deruxtecan) to treat HER2-positive breast cancer in India in January 2024.

mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more that 150 countries including Europe and the US for various autoimmune disorders.  mAbxience (majority owned by Fresenius Kabi, partially owned by Insud Pharma) will develop, manufacture and supply the etanercept biosimilar.

On 20 September 2023, mAbxience reached an agreement with Abbott to commercialise several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.

A Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated that SB15, its biosimilar to Regeneron’s Eylea® (aflibercept), had comparable efficacy, safety, pharmacokinetics and immunogenicity to Eylea® up to week 56 in patients with neovascular age- related macular degeneration  (nAMD).  The study also showed that switching from Eylea® to SB15 maintained comparable clinical efficacy and safety.  The authors claim that the results support biosimilarity between SB15 and Eylea®.

Samsung Bioepis announced the phase III switching study results for SB15 on 7 October 2023.

Outlook Therapeutics announced that it has submitted a Special Protocol Assessment (SPA) request to the FDA regarding the required additional adequate and well-controlled study of ONS-5010.  An SPA is a process in which sponsors ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies.

On 27 November 2023, Outlook announced it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010.  It stated the FDA said Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment-naïve patients with a primary efficacy endpoint at 2 months.

The FDA is expected to provide a response to the SPA in early February 2024.

Roche announced that the FDA has accepted for priority review its Biologics License Application (BLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods.  The BLA relates to treatment of adult and paediatric patients aged one year and older with food allergy.  The FDA expects to make a decision on approval in Q1 2024.  In the US Genentech (Roche) and Novartis  co-promote Xolair®.

Merck announced that the US FDA has accepted for priority review its new Biologics License Application (BLA) for V116, its investigational 21-valent pneumococcal conjugate vaccine for invasive pneumococcal disease and pneumococcal pneumonia in adults.  The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of 17 June 2024.

Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved validity period of the clinical trial drugs without obtaining approval from the MFDS, and deviated from the approved labelling requirements.  The MFDS confirmed Samsung breached the Pharmaceutical Affairs Act and invoked a suspension of the clinical trial until 2 February 2024, despite the clinical trials having already concluded.

On 7 October 2023, Samsung Bioepis announced its Phase III switching study results for SB15 which confirmed interchangeability and biosimilarity with Eylea®.

Celltrion filed an inter partes review (IPR) petition challenging Regeneron’s Eylea® aflibercept  patent no. 11,253,572, in IPR proceeding IPR2024-00260.  Celltrion also filed a motion for joinder with Samsung Bioepis’ IPR (IPR2023-00884) of the ‘572 patent which was instituted in November 2023.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

CSL announced that the FDA accepted its Biologics License Application (BLA), and the EMA has accepted its Marketing Authorisation Application (MAA), for CSL312 (garadacimab) to treat prophylactic treatment for hereditary angioedema (HAE).  If approved, CSL312 would be the first treatment for HAE in the US and Europe to target activated Factor XII.