Express Pharma

OCTOBER 10, 2023

In May 2023, Alvotech and Advanz Pharma announced an extended strategic partnership with plans to supply and commercialise five proposed biosimilars in Europe, including Simponi. 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

Express Pharma

AUGUST 22, 2023

billion by 2029, according to GlobalData’s Drugs Database. AbbVie reported the largest market capitalisation decline in Q2 2023, largely due to the reported decline in sales of its blockbuster drug Humira resulting from biosimilar competition. per cent), Daiichi Sankyo (-13.5 per cent), Bayer (-13.5 per cent) and Pfizer (-10.1

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European Pharmaceutical Review

AUGUST 21, 2023

billion sales globally by 2029, this could offset Keytruda’s decline sales expected after its loss of exclusivity in 2028, GlobalData highlighted. This is mainly due to the reported decline in sales of Humira, a consequence of biosimilar competition. With the company’s monoclonal antibody drug candidate PRA023 predicted to reach $2.1

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Pharmaceutical Technology

FEBRUARY 3, 2023

However, after almost seven years of staving off competitors through patents and litigation, Humira’s market-leading position in the US will be affected as Amgen’s adalimumab biosimilar, Amjevita, started to roll out on January 31, 2023. According to GlobalData estimates, in 2022, the adalimumab biosimilars market was valued at $184.2

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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).

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Express Pharma

OCTOBER 16, 2024

billion by 2029 (3). Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally. The CRO sector in India, growing at a compound annual growth rate (CAGR) of 10.75 per cent, is projected to reach $2.5 billion by 2030 (2).

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European Pharmaceutical Review

JANUARY 18, 2024

In the US in 2029 and in Japan in 2031, Belsomra is set to lose market exclusivity. When considering the expense of ERTs and SRTs, where biosimilars face difficult market penetration due to strict regulations, this will slow market growth. GlobalData considered drug pricing and market exclusivity to be two major obstacles.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in policy allows eligible manufacturers to build up in a stepwise manner to the 10% and 20% applicable discounts by 2029 and 2031, respectively. Phase-Ins : To ease the transition to 10% and 20% discounts, the IRA has two phase-in programs for certain manufacturers. had Part D expenditures on or before August 16, 2022).

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

This bill would extend the designation deadline until September 30, 2029, a five-year extension (and would require yet another GAO report). It was shortly thereafter introduced in the Senate and referred to the Committee on Health Education, Labor, and Pensions, where it remains.

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Documentation Drug Development 64

Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.

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