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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: adalimumab

EU | EU’s CHMP recommends the approval of AVT02 (proposed adalimumab biosimilar)

September 17, 2021

Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).

Alvotech announces positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®

September 10, 2021

Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference cohort.

US | US District Court refuses to dismiss AbbVie’s Humira® infringement suit

August 26, 2021

The US District Court for the Northern District of Illinois refused to dismiss AbbVie’s Humira® (adalimumab) infringement suit against Alvotech hf. The court found that AbbVie is not required to sue the US based subsidiary listed on the aBLA form, but could sue Icelandic company Alvotech hf.

NZ | NZ’s Pharmac considering changes to adalimumab funding arrangements

August 26, 2021

NZ’s Pharmac announced that it is considering awarding Principal Supply to Amgevita® (biosimilar adalimumab). Pharmac is seeking feedback on the proposed changes to the funding arrangements.

Progenity released its Q2 2021 financial results

August 12, 2021

Progenity released its Q2 2021 financial results. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).

New study reports on the safety and efficacy of BI695501 (biosimilar adalimumab)

August 10, 2021

A new study published in the The Lancet reported that the safety and efficacy of Boehringer Ingelheim’s BI695501 (adalimumab biosimilar) in patients with Crohn’s disease is similar to reference adalimumab.

Coherus Biosciences releases its Q2 2021 financial results

August 5, 2021

Coherus Biosciences released its Q2 2021 financial results. Coherus announced that its partner, Junshi Biosciences plans to submit the BLA for toripalimab for a number of indications later this quarter. Coherus also disclosed that it anticipates a mid-2022 target action date for its BLA for biosimilar ranibizumab, and confirmed it plans to launch its biosimilar adalimumab on or after 1 July 2023.

AbbVie releases Q2 2021 financial results

July 30, 2021

AbbVie released its Q2 2021 financial results, reporting US Humira® (adalimumab) net revenues increased 7.1%, but decreased internationally 12.6% on an operational basis. AbbVie attributed this decrease to biosimilar competition.

New study confirms safety and efficacy of Celltrion’s adalimumab biosimilar

July 22, 2021

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.

UK | UK’s NICE recommends biologics for treatment of moderate RA

July 14, 2021

The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies.

Boditech Med receives export approval for AFIAS Adalimumab diagnostic kit

July 12, 2021

Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

Alvotech reaches primary completion date in AmAb switching study

June 15, 2021

Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.

UK | UK’s NICE recommends biologics for moderate RA

June 10, 2021

The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis.

EU | Celltrion to launch Yuflyma® (biosimilar adalimumab) in the EU in June

May 31, 2021

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.

AbbVie to present new data on its immunology products

May 25, 2021

AbbVie announced it will present new data from a number of studies on its immunology products including Rinvoq® (upadacitinib), Skyrizi® (risankizumab) and Humira® (adalimumab) at the EULAR 2021 Virtual Congress of Rheumatology.

US | US House of Reps Oversight Committee publishes scathing report on Humira®

May 20, 2021

The US House of Representatives Committee on Oversight and Reform published a Drug Pricing Investigation Staff Report which was scathing regarding AbbVie’s conduct regarding the sale of its blockbuster drugs Humira® (adalimumab) and Imbruvica® (ibrutinib) in pursuing ‘a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend its market monopoly, abusing orphan drug protections to further block competition, and engaging in anti-competitive pricing practices.’. 

AU | Alphapharm receives AU approval for adalimumab biosimilar

May 14, 2021

Alphapharm received approval for Hulio® (biosimilar adalimumab) in Australia.  Hulio® was approved in a 20mg/0.4mL solution for pre-filled syringe, 40mg/0.8mL solution for pre-filled syringe, and 40mg/0.8mL solution for pre-filled pen.  Viatris launched Hulio® in Canada and Japan in February this year.

Alvotech takes front foot approach and commences suit against AbbVie

May 11, 2021

Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to biosimilar adalimumab, AVT02.  Alvotech alleges that AbbVie has sought to protect its product monopoly by ‘overwhelming’ Alvotech with 60+ patent claims with questionable validity.  Specifically, Alvotech alleges that AbbVie has acted improperly by:

  • patenting purported inventions that it does not use in the production of Humira®
  • seeking multiple patents on the same invention but as part of different patent families in a manner designed to cause confusion;
  • obtaining patents through inequitable conduct;
  • by seeking patents that cover Humira® already in the prior art; and
  • obtaining patents on purported inventions that AbbVie did not invent.

AbbVie’s Humira® still holds a monopoly in the US, despite biosimilars being available in the EU, Japan, Canada and Australia.

CA | Alberta expands biosimilar switching program

May 6, 2021

The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz® or Idacio® by 01 May 2022.  This follows extensions made to biosimilar switching programs by British Columbia and New Brunswick last month.

CA | Amgen launches Amgevita® (biosimilar adalimumab) in Canada

May 4, 2021

Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.

Merck reports its vision for Organon

May 3, 2021

Merck reported the vision, focus and business model for its new standalone company, Organon.  Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).

New study indicates bimekizumab is noninferior and superior to adalimumab

April 23, 2021

A new study sponsored by UCB Biopharma SPRL indicates that bimekizumab is noninferior and superior to adalimumab at 16 weeks in the treatment of plaque psoriasis.

Samsung Bioepis releases its Q1 2021 financial results

April 23, 2021

Samsung Bioepis released its Q1 2021 financial results.  Global sales for Benepali® (biosimilar etanercept), Flixabi® (biosimilar infliximab) and Imraldi® (biosimilar adalimumab) increased 3.9% quarter-on-quarter, with Benepali® accounting for the largest share of those sales.

Boehringer Ingelheim reports on Ph III adalimumab switching study

April 23, 2021

Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity and safety.