Pharmaceutical Technology

MARCH 24, 2023

Biosimilars for AbbVie’s (US) Humira (adalimumab) have finally launched in the US, bringing an end to Humira’s 20-year reign as the best-selling biologic of all time. Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board.

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Biosimilars 59

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.

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Biosimilars Documentation Drug Pricing 130

Drug Channels

DECEMBER 17, 2020

HHS relied in part on a highly misleading ASPE study of 2018 data. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

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Biosimilars Drug Pricing 52

Big Molecule Watch

JULY 9, 2024

announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is the third biosimilar referencing STELARA to be approved by the FDA, following Amgen’s WEZLANA (ustekinumab-auub), approved in October 2023, and Alvotech’s and Teva’s SELARSDI (ustekinumab-aekn), approved in April 2024.

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Biosimilars Diabetes 49

PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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Biosimilars Clinical Pharmacology 53

Big Molecule Watch

MAY 22, 2023

Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States. Amneal developed FYLNETRA in collaboration with Kashiv Biosciences, a biopharmaceutical company located in Chicago, Illinois.

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Biosimilars Chemotherapy 72

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Labelling Biosimilars Adverse Reactions Dosage 49

Big Molecule Watch

APRIL 18, 2024

District Court for the District of New Jersey in November 2023, alleging that DRL’s proposed rituximab biosimilar to RITUXAN, DRL_RI, infringed 15 patents. The parties entered into a joint stipulation last week, dismissing all claims. The court then ordered the case dismissed.

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Biosimilars 64

Big Molecule Watch

NOVEMBER 21, 2023

District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab) and DRL’s provision of Notice of Commercial Marketing with respect to the same. Stay tuned to Big Molecule Watch for more updates on this litigation.

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Biosimilars Labelling 49

PharmaShots

FEBRUARY 1, 2023

Ximluci is expected to be available in the UK in 2023 The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults.

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Pharmaceutical Technology

JUNE 2, 2023

In a bit to challenge the market dominance of AbbVie’s Humira (adalimumab), the online pharmacy Cost Plus Drugs, owned by billionaire Mark Cuban has announced a plan to market Coherus Biosciences’ biosimilar Yusimry (adalimumab-aqvh), Cost Plus Drugs will be offering Yusimry at $569 per unit, excluding shipping and dispensing charges.

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Biosimilars Online Pharmacies Drug Pricing Communication 52

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

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Biosimilars Chemotherapy Immunity Immunization 126

pharmaphorum

AUGUST 19, 2020

The success of AbbVie’s Humira (adalimumab), which peaked at almost $20 billion in sales in 2018, demonstrates the potential of inflammatory diseases drugs to make mega-bucks.

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Biosimilars 105

pharmaphorum

AUGUST 12, 2020

If approved, pegunigalsidase alfa will compete with established ERT drugs like Sanofi Genzyme’s Fabrazyme (agalsidase beta) and Takeda’s Replagal (agalsidase alfa), as well as Amicus Therapeutics’ newer, orally-active drug Galafold (migalastat) which made its debut in 2018 and is designed to bind and stabilise the enzyme in the body.

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Biosimilars 98

pharmaphorum

NOVEMBER 17, 2022

The 2019 VPAS agreement was published on 5 December 2018 and an annexe showed that growth rate of branded medicines spend was expected to go up over time. Source: DHSC (2018) and DHSC (2022). One of those is Celltrion Healthcare, which says that it is no longer viable to continue to supply the NHS with biosimilars.

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Biosimilars 98

Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

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Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

Pharma Pathway

SEPTEMBER 12, 2022

Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics. With more than 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include API’S, generic and biosimilar. Eligibility: 2018, 2019, 2020, 2021, 2022 passed outs Only. Chemist/ Jr.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 52

Big Molecule Watch

AUGUST 16, 2023

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “ Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products ” and “ Classification Categories for Certain Supplements under BsUFA III ”, respectively.

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Biosimilars 52

pharmaphorum

OCTOBER 28, 2022

In 2018, she was nominated by Pharmaceutical Marketing Europe as one of the 30 most influential women in UK Healthcare, and in September 2019 appointed by the UK’s Chief Scientific Officer to be an Ambassador for Women in Science and Engineering (WISE). She is an SME in market access, rare disease and biosimilars.

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Biosimilars 122

Pharma in Brief

FEBRUARY 25, 2024

Background on the GSUR List Since 2018, Heath Canada has disclosed abbreviated new drug submissions ( ANDSs ) that it is currently reviewing on the Generic Submissions Under Review List ( GSUR List ). In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).

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Biosimilars 52

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

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Biosimilars Labelling Drug Pricing 45

FDA Law Blog: Biosimilars

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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Clinical Pharmacology Drug Development 105

pharmaphorum

MARCH 17, 2022

Chugai claimed that Ultomiris uses a delivery technology designed to reduce the dosing frequency of the drug that infringes on patents it holds, filing lawsuits in the US and Japan in 2018 in defence of its intellectual property.

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Biosimilars 52

FDA Law Blog: Biosimilars

MAY 13, 2024

In fact, in 2018, FDA emphasized that leveraging the use of RWD and RWE in regulatory decision-making is “a top strategic priority for the FDA.” RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology.

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Medical Records Documentation 111

pharmaphorum

SEPTEMBER 29, 2020

Toripalimab was first approved in second line metastatic melanoma in China in December 2018 and launched in February last year. In China, Junshi plans to file results with the country’s regulator, the National Medical Products Administration (NMPA) and other national regulators in the near future.

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Chemotherapy Biosimilars 40

pharmaphorum

MAY 25, 2022

Highly-effective biologic therapies like AbbVie’s $20 billion-a-year Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab) – plus biosimilar versions of the drugs – are widely used to treat patients at the moderate to severe end of the spectrum. Image by Anastasia Gepp from Pixabay.

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Labelling Biosimilars 52

HealthPartners

JULY 21, 2021

Represents 2018 performance, latest published figure. Represents 2018 performance, latest published figure. We monitor the drug pipeline to predict and plan for new and lower-cost drug options like generics and biosimilars. Alternative biosimilars. Cost performance (PMPM) of leading PBMs. Generic use rate of leading PBMs.

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Biosimilars Specialty Pharmacies Mail-Order Pharmacies Health Insurance Companies 52

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. RESULT: Humalog is still Lilly’s second top-selling drug with nearly $3 billion in sales in 2018. Between December 1, 2018 and January 31, 2019, 65% of erectile dysfunction prescriptions filled were for Viagra or its generic version 12.

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Prescription Filling Drug Pricing Biosimilars Compounding 52

FDA Law Blog: Biosimilars

DECEMBER 13, 2023

An Opportunity to Convene this New Advisory Committee for All Rare Disease Therapies In 2018, HP&M attorneys Frank Sasinowski and James Valentine proposed a Rare Disease Center of Excellence (which we blogged about here ). However, there is tremendous potential in such a committee to advance rare disease drug development broadly.

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Drug Development 59

FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020.

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Documentation 115

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ).

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Documentation 64

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 2018 [cited 2024May]. Premier Consulting [Internet]. researchspace.auckland.ac.nz.

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Drug Development Biosimilars Documentation Labelling 103

PharmaShots

JUNE 28, 2023

The increase in ENBREL sales for 2019 vs 2018 was primarily driven by favorable changes to estimated sales deductions and an increase in net selling price, partially offset by lower unit demand. Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. Enbrel Prescribing Information 3.

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Biosimilars Insurance Coverage and Processing Dosage Compounding 40

PharmaState Academy

MAY 16, 2023

Over the next 15 to 20 years, you can expect pharma business models of today to be metamorphosed by biopharmaceuticals and biosimilars. Medical representatives will have to transform into knowledge workers and their upline too will have a redefined leadership role to play.

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Biosimilars Dosage Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2023

The nearly $7 billion window covering industry was well aware of the dangers of dangling cords and put industry standards in place in 2018 and updated them in 2022. Circuit Court of Appeals described in a recent opinion as an “aggressive timeline for industry compliance.” However, as the D.C.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

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Drug Pricing Biosimilars Dosage Documentation 45

FDA Law Blog: Biosimilars

JULY 25, 2023

The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans. According to several studies, nitrosamines are a potentially potent carcinogen, depending on the length and depth of exposure. What is FDA doing about NDRSIs?

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Compounding 52