pharmaphorum

AUGUST 12, 2020

billion by 2027, driven by new oral drugs such as Galafold as well as gene therapies that are still in clinical development. It says ERTs will remain a key part of Fabry treatment, although the first generation drugs could start to see biosimilar competition in the intervening period. billion last year to $3.8

Biosimilars 98

Biosimilars 98

Big Molecule Watch

DECEMBER 28, 2023

As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The ’865 patent, which the court found to be valid and infringed, is expected to expire in June 2027. 271(e)(4)(D).

Biosimilars 69

Biosimilars Diabetes 69

FDA Law Blog: Biosimilars

JANUARY 29, 2025

Will he wait until the next PDUFA reauthorization in 2027 to instill additional changes at the agency? Kennedy has been critical of FDAs reliance on user fees to fund its mission. Will Kennedy try to overturn the user fee system thats been in place since 1992?

Vaccines 59

Vaccines 59

Big Molecule Watch

MARCH 1, 2024

collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The ’865 patent does not expire until June 2027. Mylan (aflibercept) BPCIA case filed As we previously reported , trial in Regeneron Pharmaceutical, Inc.’s

Biosimilars 53

Biosimilars 53

FDA Law Blog: Biosimilars

JUNE 8, 2023

FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

Communication 53

Communication Biosimilars Documentation 53

European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. Rani recently partnered with Celltrion for the development of RT-111.

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

FDA Law Blog: Biosimilars

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. We, and many stakeholders, agree that RWD and RWE can play an invaluable role.

Medical Records 111

Medical Records Documentation 111

pharmaphorum

SEPTEMBER 22, 2022

The “US-first” mindset will lead to higher proportions of American patients in its clinical trials and investment in “capability and talent” in the US, where it aims to become a top-five player by 2027 – a big advance on its current 10th place. billion by 2024.

Biosimilars 52

Biosimilars 52

pharmaphorum

FEBRUARY 3, 2022

reaching £915 billion by 2027. Delve into the world of biologics and biosimilars and what these mean for the injectable drug market. The injectable drug delivery market is expected to rise at a compound annual growth rate of 12.9% Develop your understanding of high-volume and long-acting injectable compounds.

Compounding 52

Compounding Packaging Biosimilars Vaccines 52

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in negotiations preceding user fee reauthorization in 2027 (taking effect in FY2028, which begins on October 1, 2027).

Labelling 64

Labelling 64

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

Documentation 59

Documentation Communication 59

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

Dosage 59

Dosage 59

FDA Law Blog: Biosimilars

NOVEMBER 22, 2023

Moreover, California recently enacted the California Food Safety Act , prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as of January 1, 2027. In addition, New York introduced a similar bill prohibiting certain food additives, including BVO.

52

52

FDA Law Blog: Biosimilars

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

Communication 45

Communication 45

FDA Law Blog: Biosimilars

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.”

Drug Development 52

Drug Development Documentation 52

FDA Law Blog: Biosimilars

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards).

Communication 45

Communication 45

FDA Law Blog: Biosimilars

MARCH 5, 2024

To the extent that AstraZeneca alleged that CMS would cause it this type of harm in 2027, the court found that allegation to be too speculative. Because the alleged harm arises from the Act, not from the Guidance, the court found that AstraZeneca did not meet the causation or redressability elements of standing under this argument.

Dosage 64

Dosage Drug Pricing 64

FDA Law Blog: Biosimilars

JULY 24, 2023

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027.

52

52

pharmaphorum

FEBRUARY 23, 2021

The registry study will presumably feed into the longer-term assessment of additional benefit, expected in 2027. Meanwhile, just like many countries, the Germans have seen the potential for savings from the use of biosimilars. The results of this won’t come out until November 2021 and will be seen as provisional. Tougher pricing?

Biosimilars 86

Biosimilars Medical Records 86

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

Biosimilars 52

Biosimilars Labelling Diabetes Compounding 52

pharmaphorum

JULY 18, 2022

Polpharma has become the first company to file for approval in the EU of a biosimilar version of Biogen’s blockbuster multiple sclerosis therapy Tysabri. It had expected the drug would not face biosimilar competition in Europe until at least 2027.

Biosimilars 52

Biosimilars 52

pharmaphorum

JULY 26, 2022

Regulators in the US and Europe have started to review Novartis’ biosimilar version of Biogen’s big-selling multiple sclerosis therapy Tysabri, which could reach the market next year. It had expected the drug would not face biosimilar competition in Europe until at least 2027.

Biosimilars 52

Biosimilars 52

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding 59