BioBlast®

The Korea Biomedical Review has reported that Celltrion has explained to shareholders the delay in obtaining US approval for its Humira® adalimumab biosimilar Yuflyma®. Despite obtaining EMA approval in December 2020, Celltrion confirmed that FDA took issue with Celltrion’s overseas and end-product manufacturing plants. Celltrion has rectified the problems and the FDA will complete a final review by May 2023. We have previously reported on Yuflyma®’s progress and approvals including its EU approval in December 2020, in CA on 24 December 2021 and in AU on 28 February 2022.   Celltrion is licensed to supply Yuflyma® in the US from July 2023 pursuant to its settlement with AbbVie.

Korea Biomedical Review reported that Celltrion has obtained approval from South Korea’s Ministry of Food and Drug Safety for a domestically manufactured Yuflyma® (biosimilar adalimumab).

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

• Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
• Tysabri® (natalizumab): amended listings (removing a requirement for neurologists prescribing natalizumab to be registered with the Tysabri Australian Prescribing Program) recommended by PBAC.
• Epidyolex® (cannabidiol): not recommended for the treatment of Lennox-Gastaut syndrome, as the incremental cost effectiveness ratio was deemed to be unacceptably high at the price proposed.
• Keytruda® (pembrolizumab): amended listings (increasing the max number of repeats, and maximum number of cycles in a lifetime) recommended by PBAC.
• Stelara® (ustekinumab): vial for IV infusion and PFS recommended for the treatment of moderate to severe ulcerative colitis. 90mg/1mL PFS recommended for the treatment of Crohn disease and severe chronic plaque psoriasis.

Celltrion announced the commencement of Ph III clinical trials regarding Yuflyma® (biosimilar adalimumab) in Estonia.  This trial will run for 13 months and will be used to support Celltrion’s application for interchangeability in the US.  Yuflyma was approved in the EU in February 2021, and in Canada in December 2021.

Celltrion Healthcare has reportedly filed an IND application to the FDA for a phase III clinical trial to demonstrate the interchangeability of its Yuflyma® (adalimumab) biosimilar and AbbVie’s Humira®.  The trial will involve 366 patients with plaque psoriasis.  Following Celltrion’s aBLA filing in late 2020 and its settlement with AbbVie in Q1 of 2021, Celltrion plans to launch in the US on 1 July 2023.

Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to Celltrion’s Yuflyma^TM (biosimilar citrate-free adalimumab).  Under the agreement, Hikma will gain exclusive commercialisation rights to Yuflyma^TM in all of its Middle East and North Africa (MENA) markets.  Hikma has launched a number of Celltrion biosimilars: Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab), with the launch of Remsima® SC (subcutaneous infliximab) in progress.

At the PBAC meetings 6 – 8 July, Australia’s PBAC considered a number of applications for biologic and biosimilar products, including:

Celltrion’s Yuflyma® (biosimilar adalimumab): requesting listing under the same conditions as Humira®

Korea Biomedical Review reported that Celltrion has a licence from AbbVie enabling the launch of Yuflyma® (Celltrion’s biosimilar adalimumab) in the US from July 2023.  Celltrion expects to receive approval for Yuflyma® this year.  Celltrion previously announced in February 2021 that it had completed patent settlements in the US and was approaching settlements in Europe.

Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada.  Yuflyma® is approved in Canada for ten indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and paediatric uveitis.

Australia’s TGA approved Celltrion’s Yuflyma® (biosimilar to AbbVie’s Humira® adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis. Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis.

Celltrion launched Yuflyma® (high concentration citrate-free biosimilar adalimumab) in Korea.

Health Canada approved Celltrion’s Yuflyma® (100mg/mL biosimilar adalimumab) for all indications as Humira®.

A new study published in Rheumatology reported that the safety and efficacy of Celltrion’s CT-P17 (biosimilar adalimumab) were comparable after one year of treatment, including for patients who switched from reference adalimumab after 24 weeks.

The Korea Herald has reported that Celltrion will launch Yuflyma® in the EU in June.  Citing ‘industry sources’ and a Celltrion official, the article discloses that Celltrion will initially launch Yuflyma® in six EU countries including Spain, before launching in an additional 7 EU countries in Q3 2021, and 3 more in Q4 2021.

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’.

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.

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.