European Pharmaceutical Review

JANUARY 30, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for a citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz ® (adalimumab). The adalimumab reference medicine (Humira ® ) was first approved with an adalimumab concentration of 50mg/ml.

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Biosimilars Packaging 98

Pharmacy Times

FEBRUARY 15, 2024

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

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Biosimilars 61

LifeProNow

APRIL 6, 2023

April 3, 2023 : “Sandoz, a global leader in off-patent (generic and biosimilar) medicines announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz ® (adalimumab).

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Safe Biologics

MAY 21, 2024

Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a r esponse published in GaBI Journal. Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such.

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Biosimilars Documentation 100

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

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.

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Biosimilars Drug Pricing Packaging Labelling 130

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

European Pharmaceutical Review

JANUARY 31, 2025

Over 100 biosimilar medicines are approved for nearly 30 reference medicines, testimony to the rigour of the scientific standards leading to the European authorisation process. This makes biosimilar medicines highly relevant. A significant number of the possible biosimilar candidates are not blockbuster medicines.

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Biosimilars 52

Pharmaceutical Technology

JULY 25, 2022

This also includes biologics and biosimilars, which go through a different regulatory journey. There has been major growth in interest in biosimilars in recent times, says Watanabe. Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez.

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Biosimilars Medical Schools Dosage 119

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

pharmaphorum

OCTOBER 28, 2022

She is an SME in market access, rare disease and biosimilars. Angela spent a decade in pharma sales and marketing management roles with MSD and BMS, prior to staring the world’s second market access agency in 1998, which she sold to IMS Health in 2013.

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Biosimilars 122

FDA Law Blog: Biosimilars

MARCH 18, 2025

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015. With this long regulatory review period, the PTO granted the statutory-maximum five-year patent term extension.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

NOVEMBER 17, 2020

The company has been working with Sanofi since 2015 on a small molecule targeting ROR gamma, a regulator of T-helper 17 immune cells. Sales of its “big three” cancer drugs Avastin, Herceptin and Rituxan are slipping away because of competition from cheaper biosimilars. Roche last year signed a $792.5

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Immunity Immunization Biosimilars 72

European Pharmaceutical Review

JANUARY 18, 2024

Comparatively, in 2015, GlobalData’s research expected that sales of therapies for Gaucher disease will reach $1.16 When considering the expense of ERTs and SRTs, where biosimilars face difficult market penetration due to strict regulations, this will slow market growth. billion by 2024.

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Drug Pricing Biosimilars Compounding 98

Express Pharma

OCTOBER 16, 2024

Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally. ABX-CRO, with ISO 9001:2015 and ISO 13485:2016, exemplifies how these standards can be integrated (13).

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Biosimilars Compounding Pharmaceutical Companies Pharmaceutical Companies 103

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. For example: Reduced stay. Revised section 8 damages.

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Biosimilars Dosage Documentation 52

pharmaphorum

OCTOBER 19, 2021

Innovent has only released top-line data from the 480-subject ORIENT-31 study so far, but said sintilimab given with its bevacizumab biosimilar Byvasda on top of chemotherapy with Lilly’s own Alimta (pemetrexed) and cisplatin had a statistically significant improvement in PFS.

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Chemotherapy Biosimilars Hospitals 52

pharmaphorum

MAY 21, 2021

It builds on the company’s four partnership projects: two with the generics and biosimilars firm Hikma, one with US biotech Inhibrix and another with an unnamed biosimilars partner. Eli Lilly, Novo Nordisk and there’s a group of biosimilar companies who already have a footprint in diabetes.”

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Biosimilars Diabetes 52

pharmaphorum

MARCH 21, 2022

The results nevertheless make Opdualag an alternative to Opdivo plus Yervoy (ipilimumab) – BMS’ notoriously hard to tolerate CTLA4 checkpoint inhibitor – which has been approved as a monotherapy for melanoma since 2011 and as a dual therapy with Opdivo since 2015.

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Biosimilars Immunity Immunization 52

FDA Law Blog: Biosimilars

MAY 7, 2023

1199, 1203 (2015) (“An agency must consider and respond to significant comments received during the period for public comment.”). DEA is taking these comments “seriously” and is considering them “carefully,” which, by the way, it is generally required to do for rulemakings issued pursuant to the Administrative Procedure Act (5 U.S.C.

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Controlled Substances 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615. —PTE applications were submitted to FDA for each of U.S. RE 44,599 and U.S. RE 44,638 and with respect to each NDA approval, See FDA Docket Nos. Earlier this month, the PTO issued a REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R.

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Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Counterarguments abound, many of which were detailed in 2015 in a publication by counsel for the American Clinical Laboratory Association ( here ). FDA’s position is, however, only one side of the story. Specific features of the PR will foreseeably yield new bases for challenge.

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Hospitals Immunization Immunity 81

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

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Documentation 59

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2024

The Breakthrough program started in 2015. Manufacturers can expect increased interaction with the review team and prioritized review of the marketing submission.” The reality, however, is quite different. Since that time, CDRH has granted 921 Breakthrough devices, and CBER has granted 12.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Subpart A – General Provisions Subpart A – General Provisions, incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015 (new § 820.7), and requirements for a quality management system (new § 820.10). The new § 820.10

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Labelling Packaging Documentation 59

FDA Law Blog: Biosimilars

MARCH 8, 2023

Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March.

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Packaging Communication 59

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. American Health and Drug Benefits. The value of Biologics (2008), pp.

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Biosimilars Dosage Pharmaceutical Companies Pharmaceutical Companies 52

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

FDA Law Blog: Biosimilars

AUGUST 11, 2024

This Draft Guidance , withdrawn in 2015, outlines FDA’s historical intent to review submissions and provide comments in a timely manner, “usually within 15 working days of the day the materials are received by FDA.” Years ago, FDA had much more robust communications about promotional materials with sponsors of accelerated approval products.

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Labelling Communication 59

PhRMA: Biologics and Biosimilars

AUGUST 27, 2015

Ten years ago today I was lucky to have evacuated from New Orleans to Atlanta and sat waiting to see what would happen with the storm of the century. Having evacuated countless times before, I could only hope this would be another false alarm.

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pharmaphorum

SEPTEMBER 8, 2020

billion in 2015. 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. Beyond significant cost savings, biosimilar uptake has been shown to simultaneously improve patient access, varying by country. In fact, an estimated 21.2

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Biosimilars Drug Pricing Chemotherapy Vaccines 99

pharmaphorum

JANUARY 14, 2021

Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. Focus on customer engagement impact.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

PharmaShots

JUNE 27, 2023

How was the ACR’22 experience for biosimilars for Biogen? We saw Biogen presented multiple results for different biosimilar molecules. Smriti: Can we talk about BIIB800, a tocilizumab biosimilar? Smriti: Can we talk about IMRALDI’s (adalimumab biosimilar) PROPER study and its design?

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Biosimilars Diabetes Immunization Immunity 40

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Patents are often described as the ‘lifeblood’ of pharmaceutical companies.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Biosimilars Packaging Vaccines 64

pharmaphorum

JULY 22, 2021

We have completed phase 2 trial of a multi-antibody drug for influenza, CT-P27, and since 2015 we have been developing a therapeutic antibody to treat the Middle East Respiratory Syndrome (MERS), CT-P38.

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Communication Packaging Biosimilars Pharmaceutical Companies 105

pharmaphorum

APRIL 16, 2021

We compared the cumulative number of New Active Substances entering each of the EU4+UK for the first time in 2020 with the average of the same measure in previous years – from 2015-2019. Using MIDAS sales data, we compared average monthly sales across the first six months on the market for NAS launched 2015 to 2020.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 95