case study

Biosimilar Drug Development

RCA was requested to develop a regulatory strategy for a European based company engaged in biosimilar drug development, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND. RCAs regulatory affairs team, confirmed that CDERs Office of Biotechnology would have jurisdiction. After reviewing all current FDA guidance, RCA proposed that the client request an initial advisory meeting as this would be their first contact with FDA.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Biosimilar Drug Development

Client Challenge

A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND.

RCA’s regulatory affairs team confirmed that CDER’s Office of Biotechnology would have jurisdiction. After reviewing all current FDA guidance, RCA proposed that the client request an initial advisory meeting as this would be their first contact with FDA.

 

RCA Approach

The first hurdle to overcome was verification that clinical data met cGCP, cGMP and FDA regulations and guidance documents pertaining to Use of Foreign Clinical Data. Since the client did not originally intend to seek FDA approval, they adhered strictly to the EMA approach which is different. RCA supported the Client as they retrieved copious amounts of records and documents. Slowly, adequate documentation was sorted from that generated, to conform to EMAs similar but different requirements. When reconstructed, this documentation essentially met FDAs requirements for cGCP.

 

The next hurdle was to pull together a briefing package on behalf of the client to support an Initial Advisory Meeting request. As the client was in the process of preparing a Biological License Application in Europe at the time, substantial Safety, Efficacy, Pharmacology and Bioanalytical data were available.

 

The client had substantial bioanalytical data comparing their biosimilar to the European marketed reference listed drug (RLD). Generation of comparative bioanalytical data that could be used to build a bridge, to the US RLD drug, was still on-going.

 

RCA submitted an FDA briefing package on behalf of the client. FDA rejected the meeting request based on insufficient bioanalytical comparison data between the clients biosimilar and the US RLD. Over a four- month time period the client was able to generate additional bioanalytical comparison data to the US RLD.

 

RCA updated the original briefing package to include additional data and resubmitted another meeting request. This time the meeting request was granted. However, due to the extensiveness of the supporting data presented in the briefing package, FDA offered the option to the client to convert the advisory meeting into a BPD type II meeting request. As a result, the client saved a significant amount of time towards their goal of filing a BLA in the US.

 

Results

The outcome of the meeting request with FDA is being withheld at this time to maintain confidentiality for our client.

 

About RCA

strategic consultingRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Client Challenge

A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy, whereby they could seek approval for their drug in the US and EU. A major challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND.

RCA’s regulatory affairs team confirmed that CDER’s Office of Biotechnology would have jurisdiction. After reviewing all current FDA guidance, RCA proposed that the client request an initial advisory meeting as this would be their first contact with FDA.

 

RCA Approach

The first hurdle to overcome was verification that clinical data met cGCP, cGMP and FDA regulations and guidance documents pertaining to Use of Foreign Clinical Data. Since the client did not originally intend to seek FDA approval, they adhered strictly to the EMA approach which is different. RCA supported the Client as they retrieved copious amounts of records and documents. Slowly, adequate documentation was sorted from that generated, to conform to EMAs similar but different requirements. When reconstructed, this documentation essentially met FDAs requirements for cGCP.

 

The next hurdle was to pull together a briefing package on behalf of the client to support an Initial Advisory Meeting request. As the client was in the process of preparing a Biological License Application in Europe at the time, substantial Safety, Efficacy, Pharmacology and Bioanalytical data were available.

 

The client had substantial bioanalytical data comparing their biosimilar to the European marketed reference listed drug (RLD). Generation of comparative bioanalytical data that could be used to build a bridge, to the US RLD drug, was still on-going.

 

RCA submitted an FDA briefing package on behalf of the client. FDA rejected the meeting request based on insufficient bioanalytical comparison data between the clients biosimilar and the US RLD. Over a four- month time period the client was able to generate additional bioanalytical comparison data to the US RLD.

 

RCA updated the original briefing package to include additional data and resubmitted another meeting request. This time the meeting request was granted. However, due to the extensiveness of the supporting data presented in the briefing package, FDA offered the option to the client to convert the advisory meeting into a BPD type II meeting request. As a result, the client saved a significant amount of time towards their goal of filing a BLA in the US.

 

Results

The outcome of the meeting request with FDA is being withheld at this time to maintain confidentiality for our client.

 

About RCA

strategic consultingRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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