Photo of Aydin H. Harston

Aydin Harston combines his love for science and technology with legal expertise to advocate for his clients in all matters necessary to grow, protect, and defend their businesses.  With a Ph.D. in biochemistry and numerous scientific and legal publications, Aydin seeks to produce creative and effective  approaches to achieve his clients' goals as efficiently as possible.

  • FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.
  • FDA approves the fourth Herceptin® (trastuzumab) biosimilar—no trastuzumab biosimilar has launched in the United States to date.
  • European Medicines Agency approves ninth and tenth adalimumab biosimilars and second bevacizumab biosimilar.

As pharmaceutical drug costs attract increasing media attention

  • Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States.
  • Pfizer launches Retacrit®, an epoetin alfa biosimilar, in the United States.
  • FDA approves the first rituximab biosimilar, although it has not yet launched in the United States.
  • European Medicines Agency approves third, fourth, and fifth pegfilgrastim biosimilars and a fifth trastuzumab biosimilar, while

On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy groups, unions, and retirees, submitted a letter to U.S. Trade Representative Robert Lighthizer to raise serious concerns that the recently renegotiated version of the North American Free Trade Agreement (NAFTA) – now proposed to be called the U.S.-Mexico-Canada Free

  • European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar
  • Pfizer launches NivestymTM, a filgrastim biosimilar, in the United States
  • Only five of twelve approved biosimilars have launched in the United States

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set

  • FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)
  • European Medicines Agency approves third and fourth trastuzumab, fourth infliximab, and fifth, sixth and seventh adalimumab biosimilars
  • Only four of twelve approved biosimilars have launched in the United States

As pharmaceutical drug costs attract increasing media attention and political scrutiny,

  • European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars
  • FDA has not approved any biosimilar drug in 2018
  • Only three of nine approved biosimilars have launched in the United States

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S.

Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are typically derived from living cells and used in the treatment, diagnosis, or prevention of disease. Most biologics are produced by genetically engineering living cells to express the therapeutic proteins rather than through traditional chemical synthesis. As proteins

  • U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars
  • U.S. Food & Drug Administration approves a second infliximab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales

  • European Medicines Agency newly approves two adalimumab biosimilars
  • U.S. Food & Drug Administration approves first bevacizumab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales for the top nine branded biologic