Regulation
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Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim
Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

‘There Is Always Room For Improvement’: Celltrion Reflects On A Decade Of European Biosimilars
Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.

Amgen’s $27.8bn Horizon Takeover Stipulates Biosimilar Restrictions
The FTC’s proposed consent order allowing Amgen to move ahead with its mammoth takeover of Horizon includes an interesting stipulation for industry – one involving biosimilars.

Alvotech Gets A Fresh Date For Adalimumab In US
Alvotech has revealed a US FDA goal date of 24 February 2024 for its refiled AVT02 proposed high-concentration interchangeable adalimumab biosimilar rival to Humira, as the firm provided further details of the resubmission – including an expected facility reinspection.

Biosimilar Clinical Trials: How Can Regulators Determine Waiver Early In Development?
The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.

Generics Industry Preps For Potential Entry Of Ukraine Into EU
Generics industry trade group Medicines for Europe has met with Ukrainian government officials to discuss how to plan for any future integration process.

Accord’s 12-Year-Old Prograf Generic Has US Equivalence Rating Pulled
Accord Healthcare has been told by the FDA that its generic version of Astellas Pharma’s Prograf capsules will no longer be automatically substituted for the brand following a series of post-approval studies dating back more than a decade.

Sandoz Looks To Join EU Trastuzumab Party With CHMP Thumbs Up
Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.

From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels
Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.

IGBA Welcomes Mexican Membership
The IGBA has welcomed Mexican pharmaceutical industry association ANAFAM as an associate member.

US FDA’s New Generics Chief: We Need More Flexibility For Complex Products
Iilun Murphy said Hatch-Waxman was written with immediate-release oral drugs in mind, not the complex generics becoming more popular today. The agency is evaluating the issue.

ANDA Submissions Lagging As FY2023 Nears Its End
Generic drug sponsors are on pace to submit the second-fewest number of ANDAs in a fiscal year in the history of GDUFA.

Sunsho Acquisition Finally Paying Off For Towa
After several lackluster quarters, Towa’s acquisition of Sunsho Pharmaceutical is finally paying off for the Japanese generics firm.

Sawai Outlook Improves But Japanese Generics Continue To Suffer Under NHI Price Cuts
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.

Germany In ‘Crisis Mode’ As Recent Measures Fail To Tackle Shortages
The latest developments around shortages in Germany demonstrate the need for European market reforms, according to leaders of the German and European off-patent industry trade associations.
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