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.

Biosimilars 49

Biosimilars Diabetes 49

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

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Biosimilars Labelling Diabetes 56

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.

Biosimilars 53

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

pharmaphorum

AUGUST 25, 2022

The Swiss pharma group said this morning that the separation “is in the best interest of shareholders” and will create the number one generics company in Europe and a leader in biosimilars, whilst allowing Novartis to focus on its patented medicines business. billion by 2024.

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Biosimilars Compounding Vaccines 105

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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Biosimilars Packaging Diabetes Hospitals 40

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

Quality Matters

APRIL 4, 2023

USP standards build trust in biologics and biosimilars The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. Shortening development timelines In 2018, it took approximately 18 months to bring a new mAb drug from discovery stage to the first human clinical trials.

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Biosimilars Vaccines Drug Development Diabetes 52

pharmaphorum

SEPTEMBER 8, 2020

In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. 7 With a typical price difference between reference biologics and biosimilars in the range of -15% to -80%, the immediate potential budget impacts are in the tens of billions.

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Biosimilars Drug Pricing Chemotherapy Vaccines 99

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.

Biosimilars 105

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

Pharmaceutical Technology

SEPTEMBER 26, 2022

The company told GlobalData PharmSource: “The biosimilar facilities in Austria and Slovenia would continue to manufacture biosimilars for Sandoz under a contractual agreement with Novartis. This came after an attempted sell-off starting last October was met with no formal offers from a buyer. The site employs around 250 people.

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Biosimilars Drug Development Vaccines Dosage 64

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

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

2014) June 2016 Vaxchora (Pax Vax Bermuda) Cholera vaccine for travelers $ 290 (June 2016) Aug 2017 Benznidazole (Chemo Research) Chagas disease UNK June 2018 Moxidectin (Medicines Devt for Global Health) Onchocerciasis, or river blindness UNK (May 2019) July 2018 Krintafel (GSK) P.

Vaccines 52

Vaccines 52

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).

Biosimilars 52

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.

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

pharmaphorum

APRIL 21, 2022

Without that effect the underlying growth was 5%, with rising use of biosimilars offsetting increased use of branded medicines, although IQVIA notes that the pharma sector has demonstrated “resilience and flexibility” in staging such a rapid recovery in the last two years.

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Vaccines Biosimilars 52

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.

Chemotherapy 40

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

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. In 2018, the US FDA granted ANDA approval to Glenmark's Teriflunomide Tablets in the strength of 7 mg and 14 mg. As of now, there are no the US FDA approved biosimilars available for Actemra.

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Biosimilars Diabetes Chemotherapy Immunity 49

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