The Center for Biosimilar Staff

Biocon said this week it received a Form 483 letter from the FDA related to an inspection at its insulin manufacturing plant in Malaysia, where the company will produce its insulin glargine product, referencing Sanofi’s Lantus.

, Biocon said the FDA conducted a pre-approval inspection of the facility between February 10 and February 21. The notice includes “3 observations, which we believe are procedural in nature,” the company wrote.

The follow-on product is already authorized in the European and Australian markets, where the product is regulated as a biosimilar and is sold under the brand name Semglee.

In the United States, the product has a target action date set for June; Biocon said in its announcement it does not “believe the outcome of this inspection does not in any way impact the commercialization plans."

However, Biocon’s Malaysian plant has been the subject of numerous regulatory challenges in 2018 and 2019. The company received a Form 483 from the FDA, inclusive of 6 observations, in 2018, and another inspection of the site in June and July 2019 yielded another Form 483 with 12 observations. 

In August 2019, it received a certificate of good manufacturing practice from the European Medicines Agency’s Irish inspection authority. 

With the latest notice, Biocon said it is confident of addressing the observations "expeditiously" and said it is committed to "global standards of Quality and Compliance."

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This is the third Form 483 Biocon has received for the insulin plant in 3 years. 

Biocon Says FDA Issues Form 483 to Insulin Plant in Malaysia

The FDA said Monday it launched the first phase of its improvement to the Purple Book by moving from a list format to a 

, so the public can more easily search biosimilar and biologic products.

; the FDA said; while the update to the new database continues, the FDA said the static PDF will continue to house information on all FDA-licensed biological products. The initial Purple Book version contains a limited data set that includes all approved biosimilar products and their related reference products, with a simple search and advanced search function.

The FDA said it will also publish a Federal Register notice and open a docket to gather public comment on the database to inform the next phases of development; they will also take user testing and stakeholder input into consideration as additional functionality and improvements are developed and implemented in subsequent phases.

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, 

Once the new database update is completed, the list/PDF format version will cease updates. The updated database is “intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including biosimilar and interchangeable products, and to advance public awareness about licensed biological products,” the FDA said.

“Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications,” FDA Commissioner Stephen M. Hahn, MD, 

The new database includes information about FDA-licensed biological products, such as the product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, marketing status, and more. The enhancements also include more information about approved biological products (such as including information pertaining to exclusivity, and whether a product has demonstrated that it is biosimilar to, or interchangeable with, a reference product), intended to help patients and industry track the licensure statuses of biosimilar and interchangeable biological products, and to aid prescribers and pharmacies in identifying life-saving, and potentially cost-effective medications.

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.

FDA Launches Searchable Database Intended to Replace Static Purple Book Lists

Pfizer's trastuzumab biosimilar to Herceptin, Trazimera, launched Wednesday in the United States.

Trazimera is available for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The company said last month that Trazimera will have a wholesale acquisition cost (WAC) of $80.74 per 10 mg, a 22% discount to the WAC of Herceptin. In January, Pfizer launched its rituximab product, Ruxience (referencing Rituxan), and its biosimilar bevacizumab Zirabev (referencing Avastin).

With Trazimera in place, Herceptin now has 3 biosimilar competitiors. Besides Trazimera, the other 2 are the Mylan and Biocon biosimilar trastuzumab, 

This is the sixth biosimilar to launch within 120 days, making for 15 biosimilars launched in the U.S. The launch of Trazimera officially makes the Herceptin market one of the most competitive therapeutic markets in the U.S. (now having three biosimilars competing with one reference product) and the Herceptin market could have as many as five biosimilars competing in it by the end of 2020

With Trazimera in place, Herceptin now has 3 biosimilar competitiors.

Pfizer Launches Trastuzumab Biosimilar

 today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug, referencing Neulasta, under the name Udenyca.

Coherus indicated that its data package for the drug included analytical similarity data, a 3-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy volunteers, as well as an immunogenicity package including a dedicated immunogenicity study in more than 300 patients.

"The positive opinion issued by the CHMP today is a significant milestone for Coherus, as it validates both our Udenyca biosimilarity package as well as our development platform as a whole," said Denny Lanfear, president and CEO of Coherus BioSciences, in a 

The opinion is welcome news for the biosimilar developer; in 2017, Coherus experienced a setback for CHS-1701 when received a Complete Response Letter (CRL) from the FDA. The CRL cited a need for a reanalysis of a subset of samples with a revised immunogenicity assay, as well as for additional manufacturing information. In May 2018, Coherus resubmitted its Biologics License Application in May 2018.  

Also today, Accord Healthcare received a positive CHMP 

 for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.

The opinion was based on a phase 1 PK and PD study in healthy volunteers as well as a phase 3 study in patients with breast cancer who were receiving docetaxel, doxorubicin, and cyclophosphamide chemotherapy.

Accord has long-standing experience in the European biosimilars space with its filgrastim biosimilar, Accofil, which was approved in 2014. “Since then the product has been used over 2 million times,” said Binish Chudgar, vice chairman and managing director of Intas Group, Accord’s parent company. “Accord has gained valuable experience in bringing biosimilar medicines to market. Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be a first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz,” he added.

Both products will now await final clearance by the European Commission before they will be authorized for marketing in the European Union and European Economic Area.

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.
 

The Center for Biosimilar Staff

Biocon Says FDA Issues Form 483 to Insulin Plant in Malaysia

FDA Launches Searchable Database Intended to Replace Static Purple Book Lists

Pfizer Launches Trastuzumab Biosimilar

Coherus, Accord Both Receive Positive CHMP Opinions for Pegfilgrastim Biosimilars