European Pharmaceutical Review

MAY 22, 2024

The European Commission (EC) has approved the first and only biosimilar versions of the reference medicines Xgeva ® and Prolia ® in Europe. About the denosumab biosimilars Wyost and Jubbonti both contain the same active ingredient (denosumab), a human monoclonal antibody.

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Biosimilars 98

Big Molecule Watch

JUNE 5, 2024

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars.

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Biosimilars 62

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 98

Big Molecule Watch

OCTOBER 23, 2024

As we previously reported , on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved aflibercept biosimilar, PAVBLU (aflibercept-ayyh).

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Biosimilars 62

Big Molecule Watch

OCTOBER 18, 2024

announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s PROLIA ® (denosumab) that treats osteoporosis. On October 8, 2024, Teva Pharmaceutical Industries Ltd.

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Biosimilars 44

Big Molecule Watch

SEPTEMBER 18, 2024

On September 13, 2024, Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar of EYLEA®. Altos Biologics stated that it expects to receive approval from the EMA by 2025. On July 1, 2024, Alteogen’s subsidiary, Altos Biologics, Inc.,

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Biosimilars 57

European Pharmaceutical Review

JUNE 9, 2023

Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. The contact is valued at some $411 million, according to a company filing.

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Biosimilars 98

BioPharma Dive

MAY 13, 2024

As commercial momentum builds, coverage incentives for the Medicare market are expected to favor biosimilars in 2025.

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Biosimilars 56

Big Molecule Watch

MARCH 27, 2024

The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. Specifically, the U.S. According to HHS, “[t]his change makes the U.S. According to HHS, “[t]his change makes the U.S.

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Biosimilars 57

Drug Channels

SEPTEMBER 4, 2024

The Humira biosimilar market just took another step forward—but remains far from its ideal state. Last week, Cigna’s Express Scripts announced that it that will follow CVS Health’s CVS Caremark business and remove Humira from its largest commercial formulary in favor of multiple biosimilars.

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Biosimilars Labelling 52

Safe Biologics

NOVEMBER 14, 2024

SAVE THE DATE: ASBM and GaBI to Present Webinar on the Biosimilar Red Tape Elimination Act October 31st On October 31st, ASBM and the Generics and Biosimilar Initiative will present a webinar focusing Senate Bill 2305, the Biosimilar Red Tape Elimination Act. Health policy experts will review current U.S.

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Biosimilars 130

Big Molecule Watch

JULY 25, 2024

Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability. To date, the FDA has approved thirteen biosimilar products as interchangeable.

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Biosimilars 62

Big Molecule Watch

APRIL 22, 2024

On April 16, Alvotech and Teva announced the FDA approval of SELARSDI (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). SELARSDI is now the second ustekinumab biosimilar to be approved by the FDA, following FDA approval of Amgen’s WEZLANA (ustekinumab-auub) in October 2023.

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Biosimilars 57

Big Molecule Watch

MARCH 6, 2024

regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept). Under the agreement, Biocon can launch YESAFILI in Canada no later than July 1, 2025. patent litigation related to biosimilars of EYLEA (aflibercept) can be found on the Big Molecule Watch’s BPCIA Litigation Tracker. On March 4, Biocon Biologics Ltd.

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Biosimilars 57

Big Molecule Watch

MARCH 6, 2024

and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. Market Entry Date for Ustekinumab Biosimilar appeared first on Big Molecule Watch. Amgen secured a U.S.

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Biosimilars 62

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

pharmaphorum

FEBRUARY 23, 2022

Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars. The short story so far.

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Biosimilars Vaccines 98

Big Molecule Watch

SEPTEMBER 28, 2023

Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. Oncology, Women’s Health, and Respiratory Disease Biosimilars: Abbott has announced an expansion of its agreement with mAbxience Holdings S.L.

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Biosimilars 57

FDA Law Blog: Biosimilars

SEPTEMBER 4, 2024

HP&M”) is proud to announce that 16 of the Firm’s attorneys have been selected to the 2025 edition of The Best Lawyers in America®. Hyman has been rightfully chosen as a 2025 “Lawyer of the Year.” Hyman, Phelps & McNamara, P.C. (“HP&M”) Founding Director Paul M. Additionally, Kalie E. Richardson, James E.

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Express Pharma

FEBRUARY 29, 2024

Biocon Biologics has signed a settlement and license agreement with Janssen Biotech, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara, in the US. The agreement licenses the company to launch in the US, in February 2025, once approved by the US FDA.

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Biosimilars Immunity Immunization 88

Big Molecule Watch

NOVEMBER 6, 2024

On November 4, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), for the treatment of several chronic inflammatory diseases.

Biosimilars 57

Biosimilars 57

STAT

AUGUST 30, 2023

government’s initial approach to negotiating drug prices could discourage cheaper biosimilar versions of more complex pharmaceuticals that eat up a high portion of total Medicare spending , Bloomberg Law explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.

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Biosimilars Drug Pricing 271

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

pharmaphorum

SEPTEMBER 20, 2022

Novartis’ soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen’s blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory filings. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and AryoGen Pharmed.

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Biosimilars 52

Big Molecule Watch

DECEMBER 13, 2023

Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17 is approved by the FDA, the license period in the United States will begin on February 22, 2025.

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Biosimilars 57

STAT

AUGUST 27, 2024

Cigna plans to remove AbbVie’s blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement in 2025, and recommend less-pricey biosimilar versions of the medicine instead , Reuters tells us. This is the second major U.S. Continue to STAT+ to read the full story…

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Big Molecule Watch

MAY 18, 2023

The USPTO has proposed several fee changes for implementation in 2025. The post Proposed USPTO Fee Changes Could Impact PGR and IPR Filing Strategies Used by Biosimilars appeared first on Big Molecule Watch. To submit comments via the portal, commenters should enter docket number PTO–P–2023–0017 on the homepage.

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Biosimilars 78

Express Pharma

AUGUST 28, 2024

Biocon Biologics (BBL), a biosimilars company and subsidiary of Biocon announced today that it has signed a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) for the global commercialisation of its biosimilar product Bmab 1200. FDA approval.

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Biosimilars 104

Pharmaceutical Commerce

JULY 3, 2024

The Stelara biosimilar will be commercialized by Sandoz, and is expected to launch by February 2025 for multiple indications, including for the treatment of adult patients with active psoriatic arthritis.

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Biosimilars 52

Pharmacy Times

OCTOBER 18, 2023

Jensen notes that although she expects there will be a lot of FDA approvals in 2023 and 2024, there likely will not be another biosimilar “boom” until 2025.

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Biosimilars 26

Big Molecule Watch

JULY 26, 2024

On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved ustekinumab biosimilar to STELARA® in Europe, is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

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Biosimilars 67

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. Sandoz Reports Real World Study Results of GP2013 (biosimilar, rituximab) for the Treatment of Rheumatoid Arthritis Date- May 08, 2023 Product: GP2013 (biosimilar, rituximab) The study incl. 84% vs 64%) & 2yr. (60%

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Biosimilars Packaging Diabetes Pharmaceutical Companies 40

Big Molecule Watch

AUGUST 26, 2024

On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) EYLEA (aflibercept). Alvotech is also developing AVT29, a high dose (8 mg) biosimilar of EYLEA.

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Biosimilars 57

Big Molecule Watch

MAY 15, 2024

As we previously reported, in May 2023 , Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab Litigation”).

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Biosimilars 62

Pharmaceutical Technology

AUGUST 8, 2023

The deal sets the biosimilar’s potential US launch date to no later than April 2025, following two agreements signed earlier this year.

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Biosimilars 52

Big Molecule Watch

JUNE 13, 2023

announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States. According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than February 21, 2025.”

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Biosimilars 67

Big Molecule Watch

NOVEMBER 6, 2023

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA.

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Drug Pricing Biosimilars 67