BioBlast®

British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.

A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.

Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.

Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product.  Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.

A number of changes have been made to the PBS listings of adalimumab. From 1 April:

• The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
• Humira 100mg/ml 20mg and 40mg products will be listed and A flagged against the 50mg/ml Humira formulations, and the 50mg/ml Humira product will be phased out over 12 months but cannot be prescribed after 1 April (ie the pharmacies will honour scripts written prior to 1 April).
• Humira 100mg/ml 80mg syringe and pen products will be PBS listed but will not be A flagged as they are not considered equivalent to the “original” Humira formulation/product.

Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.

Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.

The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injections’.

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

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.

Viatris announced it has launched Hulio® (biosimilar adalimumab) in Canada. Hulio® is available in a 50mg/ml formulation (40mg/0.8mL) and is approved for all adalimumab indications.

Fresenius Kabi announced it has launched Idacio® (biosimilar adalimumab) in Canada. Idacio® is available in 50mg/ml formulation (40mg/0.8mL syringe, vial and pen presentations) and is approved for all Humira® indications.

Sandoz announced that it has launched Hyrimoz®, its 50mg/mL biosimilar adalimumab in Canada. Hyrimoz® was approved by Health Canada in November 2020 with a full label. It was also previously launched in Europe in 2018.

Coherus Biosciences announced the FDA has accepted the BLA for its biosimilar adalimumab candidate (CHS-1420). Coherus also announced that it plans to launch its product in the US on or after 01 July 2023. Coherus had previously disclosed that its license with AbbVie would commence in the US in December 2023.

Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.

Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.

In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.

Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. If approved, this will be the first registered high concentration, citrate-free adalimumab biosimilar anywhere in the world.

Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).

Alvotech announces the FDA and EMA have accepted its regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.