European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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Biosimilars Packaging Pharmaceutical Companies Pharmaceutical Companies 88

European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). A new European biosimilar approval “This first marketing authorisation for biosimilar ustekinumab in Europe offers the potential to expand substantially patient access through competition.

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Biosimilars Immunity Immunization 103

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024. Read the concept paper here.

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Biosimilars Documentation 100

Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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Biosimilars Communication Labelling Documentation 62

Big Molecule Watch

APRIL 26, 2024

On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech, Inc.’s ’s SIMPONI (R) and SIMPONI ARIA (R). ” AVT05 has not yet received regulatory approval.

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Biosimilars 70

Pharmacy Times

MARCH 8, 2024

Cardinal Health released its 2024 biosimilars report, including research and in-depth analyses on legislative development, payer landscapes, and new treatments in the pipeline.

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Biosimilars 51

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Sustainable biosimilar competition in Europe: can it be achieved? Stelara biosimilars in the US market The first Stelara biosimilars are expected to enter the US market in 2025. “We

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Biosimilars 92

Pharmaceutical Technology

AUGUST 24, 2023

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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Biosimilars 98

Safe Biologics

JANUARY 6, 2024

In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.

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Biosimilars 100

Big Molecule Watch

FEBRUARY 1, 2024

Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. FDA Accepts Accord BioPharma’s BLA for Ustekinumab Biosimilar On January 4, 2024, Accord BioPharma, Inc.

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Biosimilars 62

Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Click here to see the original post from September 2023.

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Biosimilars Labelling 67

Big Molecule Watch

JANUARY 17, 2024

collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. District Court for the District of Delaware, alleging infringement of 6 patents under the BPCIA based on Samsung’s submission of an aBLA for SB12, a proposed biosimilar to SOLIRIS (eculizumab). Alexion Pharmaceuticals, Inc. Samsung”) in the U.S.

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Biosimilars Compounding 62

Pharmacy Times

APRIL 10, 2024

In a review, investigators focused on ranibizumab (Lucentis; Genentech), aflibercept (Eylea; Regeneron), and bevacizumab (Avastin; Genentech) as growth opportunities in the biosimilar space.

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Biosimilars 43

Pharmacy Times

DECEMBER 21, 2023

The biosimilars landscape is set to witness significant growth, particularly in therapeutic areas like ophthalmology and immunology, with a focus on blockbuster biologics like Humira, Stelara, and Eylea.

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Biosimilars 52

Big Molecule Watch

DECEMBER 26, 2023

announced the successful completion of the transition of the acquired biosimilars business in approximately 120 countries, a year ahead of schedule. The trial is expected to begin enrolling participants in mid-2024. The post Biosimilar Deals Updates: Biocon, AstraZeneca appeared first on Big Molecule Watch.

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Biosimilars Vaccines Hospitals 62

European Pharmaceutical Review

FEBRUARY 26, 2024

At its February 2024 meeting, the EMA’s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. CHMP meeting highlights: January 2024 The post CHMP meeting highlights: February 2024 appeared first on European Pharmaceutical Review.

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Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies 92

Big Molecule Watch

MAY 25, 2023

Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. As we previously reported , Celltrion entered into an agreement in April 2022 with AbbVie that would allow Celltrion to market its biosimilar to AbbVie’s HUMIRA product.

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Biosimilars 73

Big Molecule Watch

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. The post Biosimilars Webinar Series appeared first on Big Molecule Watch.

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Biosimilars Labelling 52

Drug Channels

APRIL 29, 2024

April is over, so it's time to hop into this month’s selection of noteworthy news: CVS Health’s formulary boosts a Humira biosimilar An insurer ditches buy-and-bill to save money for plans—but maybe not for patients? Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

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Specialty Pharmacies Biosimilars 79

Big Molecule Watch

MARCH 28, 2024

On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. ustekinumab biosimilar (FYB202), for which no entry date is publicly available.

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Biosimilars 62

Big Molecule Watch

FEBRUARY 23, 2024

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). Alvotech also announced that it expects to launch AVT04 in Q1 2024 in Canada, May 2024 in Japan, and late July 2024 in the European Economic Area.

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Biosimilars 62

Express Pharma

FEBRUARY 8, 2024

Biocon Biologics announced a five-year partnership with Sandoz AG which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD $35 million) and biosimilar Bevacizumab (market value of AUD $45 million) in Australia.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 105

Drug Channels

SEPTEMBER 7, 2022

As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. In many therapeutic areas, biosimilars’ market share is approaching 80%. I also offer some thoughts on 2023 and 2024. will face multiple biosimilar competitors. Prices are dropping while adoption accelerates.

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Biosimilars 86

Big Molecule Watch

MARCH 5, 2024

On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. The post Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA appeared first on Big Molecule Watch.

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Biosimilars 62

Drug Channels

NOVEMBER 14, 2023

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. Please note that our December 2023 webinar is *not* included with next year’s 2024 Video Webinar Series.)

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Drug Pricing Biosimilars 75

Big Molecule Watch

SEPTEMBER 29, 2023

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.

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Biosimilars 57

Pharmacy Times

JANUARY 19, 2024

In 2024, there is an urgent need for policies that will accelerate biosimilar use to achieve lower system-wide health care costs.

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Biosimilars 52

Big Molecule Watch

JUNE 28, 2023

Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS ® (ranibizumab) biosimilar candidate. There are currently two FDA-approved biosimilars to LUCENTIS ® : Biogen and Samsung Bioepis’s BYOOVIZ ® (ranibizumab-nuna) and Coherus’s CIMERLI ® (ranibizumab-eqrn).

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Biosimilars 70

Big Molecule Watch

SEPTEMBER 11, 2023

On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept). According to Formycon, FDA assigned a target action date for the aBLA of June 2024.

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Biosimilars 62

Big Molecule Watch

JANUARY 18, 2024

On January 10, Alvotech announced that the European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZPRUVO (AVT04), a biosimilar referencing STELARA (ustekinumab). The authorization covers all European Economic Area countries, as well as Iceland, Liechtenstein, and Norway.

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Biosimilars 57

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Biosimilars Labelling Communication 59

Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

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Biosimilars Drug Pricing 130

Pharmaceutical Business Review

JUNE 16, 2023

Dubbed Act4Biosimilars Action Plan, the new roadmap has been designed to boost the adoption of global biosimilar products by at least 30% points in more than 30 countries by 2030. It features crucial challenges that bar patients from gaining access to biosimilar medicines.

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Biosimilars Hospitals 59

Big Molecule Watch

NOVEMBER 9, 2023

As previously reported , in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after successful regulatory approvals.

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Biosimilars 62

Pharma Leaders

JUNE 16, 2023

Generic and biosimilar medicines provider Sandoz has introduced a global action plan to provide patients with quick access to biologic medicines. Dubbed Act4Biosimilars Action Plan, the new roadmap has been designed to boost the adoption of global biosimilar products by at least 30% points in more than 30 countries by 2030.

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Biosimilars Hospitals 52

Express Pharma

OCTOBER 10, 2023

The patent for Janssen’s second-generation, tumour necrosis factor-alpha (TNF)-a inhibitor Simponi (golimumab), is scheduled to expire in 2024 and in 2025 in the US and EU, respectively. This global study positions AVT05 as the leading contender for Simponi biosimilars in the rheumatoid arthritis (RA) market, says GlobalData.

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Biosimilars 52

Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.

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