On 24 April 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its April 2026 meeting, including positive opinions for one biosimilar and for extended indications of 9 already approved medicines.

Intas’ Rexatilux® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive CHMP opinion in April.  It will join a number of ranibizumab biosimilars approved and launched in Europe, including Samsung Bioepis’ Byooviz® (approved August 2021 in vial form and commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval), Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), and Sandoz/Lupin’s Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026).

CHMP positive opinions for extended indications include the following for BMS’ Opdivo® (nivolumab): in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL).  The same indication was approved by the FDA in March 2026.  BMS also added a cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.  A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.

AbbVie’s Skyrizi® (risankizumab) also secured a positive recommendation for an extended indication, in respect of paediatric plaque psoriasis.  The last indication approved for Skyrizi® in Europe was in July 2024, with ulcerative colitis being added to adult plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease.  There have not been any announcements of any significant biosimilar risankizumab development.

During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027.  This includes:

• biosimilars that are already on the market: Alymsys® (bevacizumab) (FDA-approved April 2022, referencing Avastin®), Releuko® (filgrastim) (FDA-approved March 2022, referencing Neupogen®), Fylnetra® (pegfilgrastim) (FDA-approved May 2022, referencing Amgen’s Neulasta®); and
• those which are yet to launch: Boncresa™ and Ozilutus™ (denosumab) (FDA-approved December 2025 in partnership with mAbxience, referencing Amgen’s Prolia® and Xgeva®) and omalizumab biosimilar, ADL018 (FDA approval pending, under licence with Alvotech, referencing Genentech/Novartis’ Xolair®).

Amneal is also expecting approvals for 6+ advanced pipeline biosimilar products in 2028-2030, including abatacept (referencing BMS’ Orencia®) certolizumab (UCB’s Cimzia®), pembrolizumab (MSD’s Keytruda®), nivolumab (BMS’ Opdivo®) and dulaglutide (Eli Lilly’s Trulicity®).

In 2030+, Amneal is planning for 10+ pipeline products to be approved, including biosimilars of dupilumab (referencing Regeneron/Sanofi’s Dupixent®), risankizumab (referencing AbbVie’s Skyrizi®) and guselkumab (referencing Janssen’s Tremfya®).

Amneal presently intends to commercialise the biosimilars itself in the US and India, with a partnership model being employed in the rest of the world.

On 4 March 2025, AbbVie announced that Skyrizi® (risankizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.

The UC indication was approved by Health Canada in October 2024.  It is the fourth indication approved for Skyrizi® in Canada following approvals for moderately to severely active Crohn’s disease (October 2022), active psoriatic arthritis (March 2022) and moderate to severe plaque psoriasis (March 2019).

Skyrizi® was approved for treatment of UC by the European Commission in July 2024, and by the US FDA in June 2024.

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Wyost®, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), for osteoporosis, giant cell tumour of bone, and bone metastases
• Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease, complex refractory fistulising Crohn’s disease, and moderate to severe ulcerative colitis.

Among the originator biopharmaceuticals, Bayer secured a recommendation for its Eylea® (aflibercept) indication expansion for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to age-related macular degeneration.  Novo Nordisk’s Ozempic® (semaglutide) also received a positive recommendation for type 2 diabetes mellitus, following its application for a new strength formulation.

Several oncology treatments received positive recommendations, including Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer.  Other cancer treatments recommended include Amgen’s Blincyto® (blinatumomab) for MRD-negative B-cell precursor acute lymphoblastic leukaemia, AstraZeneca’s Imfinzi® for use in combination with platinum-based chemotherapy for the treatment of deficient mismatch repair (dMMR) endometrial cancer, and Astellas Pharma’s Padcev® (enfortumab vedotin) for locally advanced or metastatic urothelial cancer.

AbbVie’s Epkinly® (epcoritamab) received a recommendation for relapsed or refractory diffuse large B-cell lymphoma, while Novartis’ Aimovig® (erenumab) was recommended for chronic migraine.

For hereditary angioedema, both CSL’s garadacimab and Takeda’s Takhzyro® (lanadelumab) secured positive recommendations.

Additional recommendations were granted to BMS’s Opdivo® (nivolumab) for urothelial carcinoma, MSD’s Keytruda® (pembrolizumab) for renal cell carcinoma, and Alexion Pharmaceuticals’ Ultomiris® (ravulizumab) for Neuromyelitis Optica Spectrum Disorder.

BeiGene’s Tevimbra® (tislelizumab) also received a positive recommendation for oesophageal squamous cell carcinoma.

The PBAC reports that some earlier recommendations have been extended:

• Sanofi’s Dupixent® (dupilumab) for chronic severe atopic dermatitis and uncontrolled severe asthma

Additionally, two recommendations have been rescinded:

• Celltrion Remsima SC® (infliximab) for rheumatoid arthritis
• AbbVie’s Skyrizi® (risankizumab) for Crohn’s disease

On 22 August 2024, AbbVie announced that the UK’s National Institute for Health and Care Excellence (NICE) issued final Technology Appraisal Guidance recommending Skyrizi® (risankizumab) as a treatment option for adults with moderately to severely active ulcerative colitis (UC) who cannot tolerate or have not responded to conventional, biological or TNF-alpha inhibitor treatments, or when TNF-alpha inhibitors are unsuitable.  AbbVie reports that this recommendation closely follows the UK Medicines and Healthcare Products Regulatory Agency’s approval on 21 August 2024.

Earlier this year, in July 2024, the European Commission approved Skyrizi® for UC.  The UC indication was also approved in the US in June 2024, following AbbVie’s FDA application in August 2023.

Skyrizi® received Korean approval in November 2023 for moderately to severely active Crohn’s disease.

On 26 July 2024, AbbVie announced European Commission approval of Skyrizi® (risankizumab) for moderate to severe ulcerative colitis (UC).  Skyrizi® was already approved in the EU for plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease.   

The UC indication was approved in the US in June 2024, following AbbVie’s FDA application in August 2023.   

Skyrizi® received Korean approval in November 2023 for moderate to severe active Crohn’s disease.  

On 18 June 2025, AbbVie announced that the FDA approved its Skyrizi® (Risankizumab) for ulcerative colitis, expanding AbbVie’s portfolio across inflammatory bowel disease. 

AbbVie’s Skyrizi® (risankizumab) was approved in November 2023 by the Korean Ministry of Food and Drug Safety (MFDS) to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies. 

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug Safety (MFDS) for a new indication: to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies or biologics. 

On 28 August 2023, AbbVie submitted applications to the EMA and FDA for Skyrizi® to treat moderately to severely active ulcerative colitis. 

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified. 

In November 2023, the Korean MFDS approved AbbVie’s Skyrizi® (risankizumab) to treat Chron’s disease.